Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

May 21, 2021 updated by: Shire

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
753

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Sippy Downs, Queensland, Australia, 4556
        • University of the Sunshine Coast Clinical Trials Centre
  • Austria
      • Linz, Austria, 4020
        • Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH
      • Vienna, Austria, 1140
        • Vienna Institute for Research in Ocular Surgery
      • Vienna, Austria, 1090
        • AKH - Medizinische Universitaet Wien
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital - General Campus, University of Ottawa Eye Institute
      • Waterloo, Ontario, Canada, N2L 3G1
        • University of Waterloo School of Optometry and Vision Science
  • Estonia
      • Tallinn, Estonia, 10120
        • Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital Eye Clinic
      • Tartu, Estonia, 51010
        • Tartu University Hospital
  • France
    • Haute Vienne
      • Limoges, Haute Vienne, France, 87042
        • CHU Limoges - Hopital Dupuytren
  • Hungary
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem
      • Kaposvár, Hungary, 7400
        • Kaposi Mór Hospital
      • Veszprem, Hungary, 8200
        • Csolnoky Ferenc Korhaz
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
        • SZTE Szemeszeti Klinika
    • Heves
      • Gyongyos, Heves, Hungary, 3200
        • Bugat Pal Hospital Clinexpert Gyongyos
  • Israel
      • Afula, Israel, 18341
        • HaEmek Medical Center
      • Beer Sheva, Israel, 84101
        • Soroka University Medical Center
      • Haifa, Israel, 3109601
        • Rambam MC
      • Jerusalem, Israel, 9103102
        • Sharey Zedek MC
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center-Beilinson Campus.
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Medical Center
  • Italy
      • Bologna, Italy, 40138
        • A.O.U. Policlinico San'Orsola-Malpighi
  • Poland
      • Bytom, Poland, 41-902
        • Szpital Specjalistyczny nr 1
      • Olsztyn, Poland, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka LENS
      • Tarnów, Poland, 33-100
        • Centrum Medyczne UNO-MED
      • Warszawa, Poland, 01 -364
        • Retina Sp. z o.o.
    • Malopolska
      • Krakow, Malopolska, Poland, 31-070
        • Centrum Medyczne UNO-MED
  • Puerto Rico
      • Arecibo, Puerto Rico, 00613
        • Emanuelli Research & Development Center, LLC
      • Carolina, Puerto Rico, 00984
        • Centro Dotal de Investigaciones de Servicios de Salud
      • San Juan, Puerto Rico, 00907
        • Berrocal and Associates
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2001
        • Newtown Clinical Research Centre
      • Pretoria, Gauteng, South Africa, 0082
        • Pretoria Eye Institute
      • Pretoria, Gauteng, South Africa, 0181
        • Into Research
  • Spain
      • Huelva, Spain, 21002
        • Clinica Oftalmologia Gil Piña
      • Madrid, Spain, 28010
        • Clinica Rementeria
      • Sevilla, Spain, 41092
        • Cartujavision
    • Asturias
      • Oviedo, Asturias, Spain, 33012
        • Instituto Oftalmologico Fernandez-Vega
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Arizona Eye Center
      • Phoenix, Arizona, United States, 85032
        • Cornea and Cataract Consultants of Arizona
      • Prescott, Arizona, United States, 86301
        • M&M Eye Institute
      • Scottsdale, Arizona, United States, 85260
        • Schwartz Laser Eye Center
      • Sun City, Arizona, United States, 85351
        • Walman Eye Center
    • California
      • Azusa, California, United States, 91702
        • Milton M. Hom, OD, FAAO
      • Concord, California, United States, 94520
        • Clark S Tsai Eye Center
      • Glendale, California, United States, 91204
        • Lugene Eye Institute Inc
      • Glendora, California, United States, 91741
        • Mark B. Kislinger, MD, Inc.
      • Hemet, California, United States, 92545
        • Inland Eye Specialists
      • Irvine, California, United States, 92604
        • Lakeside Vision Center
      • Lancaster, California, United States, 93534
        • Hull Eye Center
      • Long Beach, California, United States, 90808
        • Eye Physicians of Long Beach
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Macy Eye Center
      • Los Angeles, California, United States, 90020
        • Oxford Optical
      • Los Angeles, California, United States, 90020
        • Sok H. Nam, M.D. Inc.
      • Mission Hills, California, United States, 91345
        • North Valley Eye Medical Group Inc
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates, Inc.
      • Poway, California, United States, 92064
        • Arch Health Partners
      • Rancho Cordova, California, United States, 95670
        • Martel Eye Medical Group
      • Redding, California, United States, 96001
        • Shasta Eye Medical Group, Inc.
      • Roseville, California, United States, 95661
        • Clinical Trials Research
      • Sacramento, California, United States, 95815
        • Sacramento Eye Consultants
      • Santa Ana, California, United States, 92705
        • WCCT Global (PH 1 Unit)
      • Torrance, California, United States, 90505
        • Wolstan & Goldberg Eye Associates
      • Torrance, California, United States, 90505
        • East West Eye Institute
    • Colorado
      • Parker, Colorado, United States, 80134
        • Specialty Eye Care
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Eye Physicians and Surgeons
      • Meriden, Connecticut, United States, 06824
        • Ophthalmic Consultants of Connecticut
      • Willimantic, Connecticut, United States, 06226
        • Windham Eye Group
    • Florida
      • Bradenton, Florida, United States, 34209
        • The Eye Associates of Manatee, LLP
      • Delray Beach, Florida, United States, 33484
        • Bruce A. Segal, MD, PA
      • Fort Lauderdale, Florida, United States, 33309
        • South Florida Vision
      • Jacksonville, Florida, United States, 32256
        • Bowden Eye & Associates
      • Largo, Florida, United States, 33773
        • Shettle Eye Research, Inc.
      • Miami, Florida, United States, 33136
        • Bascom Palmer Eye Institute
      • Miami, Florida, United States, 33166
        • Lorites Medical Group
      • Miami, Florida, United States, 33135
        • South Florida Research Center Inc.
      • Miami, Florida, United States, 33125
        • Millenium Clinical Research
      • Miami, Florida, United States, 33125
        • Millennium Clinical Research, Inc.
      • Orlando, Florida, United States, 32825
        • Pediatric & Adult Research Center, LLC
      • Port Charlotte, Florida, United States, 33948
        • Medsol Clinical Research Center
      • Saint Petersburg, Florida, United States, 33710
        • SCORE Physician Alliance, LLC
      • Stuart, Florida, United States, 34494
        • East Florida Eye Institute
      • Tamarac, Florida, United States, 33321
        • Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
      • Tamarac, Florida, United States, 33321
        • Logan Ophthalmic Research, LLC
      • Tampa, Florida, United States, 33603
        • International Research Center
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Eye Care Centers Management, Inc.
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Jenkins Eye Care
    • Idaho
      • Nampa, Idaho, United States, 83686
        • Saltzer Medical Group
    • Illinois
      • Bloomingdale, Illinois, United States, 60108
        • Wohl Eye Center
      • Lake Villa, Illinois, United States, 60046
        • Jackson Eye
      • Peoria, Illinois, United States, 61615
        • Illinois Eye Center
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • Indianapolis, Indiana, United States, 46290
        • Midwest Cornea Associates, LLC
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Sabates Eye Centers
      • Pittsburg, Kansas, United States, 66762
        • Kannarr Eye Care
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Cincinnati Eye Institute
      • Lexington, Kentucky, United States, 40517
        • Kentucky Eye Institute
      • Lexington, Kentucky, United States, 40509
        • Koffler Vision Group
      • Louisville, Kentucky, United States, 40206
        • The Eye Care Institute
      • Louisville, Kentucky, United States, 40220
        • Senior Health Services
      • Louisville, Kentucky, United States, 40220
        • Dr. Haider Eye Care
      • Paducah, Kentucky, United States, 42001
        • Baker, Carl W
    • Louisiana
      • Gretna, Louisiana, United States, 70056
        • Lakeview Vision
      • West Monroe, Louisiana, United States, 71291
        • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
    • Maine
      • Bangor, Maine, United States, 04401
        • Eye Center Northeast
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary
      • Fall River, Massachusetts, United States, 02721
        • NECCR PrimaCare Research
      • Lexington, Massachusetts, United States, 02421
        • Shire Call Center
      • Winchester, Massachusetts, United States, 02114
        • Clinical Eye Research of Boston
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Minnesota Eye Consultants, P.A
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Lifelong Vision Foundation
      • Kansas City, Missouri, United States, 64154
        • Moyes Eye Center
      • Kansas City, Missouri, United States, 64133
        • Silverstein Eye Centers
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63131
        • Ophthalmology Associates
      • Saint Louis, Missouri, United States, 63128
        • Tekwani Vision Center
      • Saint Louis, Missouri, United States, 63131
        • Opthalmology Consultants Ltd.
      • Springfield, Missouri, United States, 65806
        • Mercy Research
    • Nevada
      • Henderson, Nevada, United States, 89074
        • NV Eye Physicians
      • Las Vegas, Nevada, United States, 89119
        • Wellish Vision Institute
      • Las Vegas, Nevada, United States, 89129
        • Emil A. Stein, M.D., Ltd.
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
      • South Orange, New Jersey, United States, 07079
        • Northern New Jersey Eye Institute
    • New York
      • New York, New York, United States, 10022
        • Farkas, Kassalow, Resnick &Associates
      • Niagara Falls, New York, United States, 14304
        • Fichte, Endl& Elmer Eyecare
      • Wantagh, New York, United States, 11793
        • South Shore Eye Care
    • North Carolina
      • Raleigh, North Carolina, United States, 27603
        • Oculus Research at Garner EyeCareCenter
      • Winston-Salem, North Carolina, United States, 27101
        • James Branch, M.D.
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
      • Cincinnati, Ohio, United States, 45247
        • Apex Eye
      • Cincinnati, Ohio, United States, 45236
        • Apex Eye Kenwood
      • Cleveland, Ohio, United States, 44141
        • Cleveland Eye Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Columbus, Ohio, United States, 43215
        • The Columbus Eye Center
      • Westlake, Ohio, United States, 44145
        • SkyVision Centers
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • IPS Research Company*
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pacific Clear Vision Institute
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18902
        • Matossian Eye Associates
      • Philadelphia, Pennsylvania, United States, 19148
        • Philadelphia Eye Associates
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Eye Center
      • Wyomissing, Pennsylvania, United States, 19610
        • Wyomissing Optometric Center
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Bluestein Custom Vision
    • South Dakota
      • Rapid City, South Dakota, United States, 59101
        • Black Hills Regional Eye Institute
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care, PA
      • Memphis, Tennessee, United States, 38120
        • Eye Specialty Group
      • Nashville, Tennessee, United States, 37205
        • Nashville Vision Associates
      • Nashville, Tennessee, United States, 37215
        • Toyos Clinic
    • Texas
      • El Paso, Texas, United States, 79934
        • Eyeland Vision
      • Houston, Texas, United States, 77025
        • Houston Eye Associates
      • Houston, Texas, United States, 77034
        • Advanced Laser Vision & Surgical Institute
      • Lakeway, Texas, United States, 78734
        • Lake Travis Eye & Laser Center
      • Mission, Texas, United States, 78572
        • DCT- Shah Research, LLC dba Discovery Clinical Trials
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute, LLC
      • San Antonio, Texas, United States, 78229
        • R and R Eye Research, LLC.
      • Sugar Land, Texas, United States, 77479
        • Lone Star Eye Care, P.A.
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research & Development, LLC
      • Saint George, Utah, United States, 84790
        • Chrysalis Clinical Research
      • Salt Lake City, Utah, United States, 84107
        • The Eye Institute of Utah
      • Salt Lake City, Utah, United States, 84117
        • Jean Brown Research
    • Virginia
      • Falls Church, Virginia, United States, 22046
        • Emerson Clinical Research Institute
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center, Inc.
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
  • Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study.
  • Participants of any age at Visit 1 (Note: participants less than (<) 3 months of age at Visit 1 must have been full-term, that is (ie,) greater than or equal to (>=) 37 weeks gestational age at birth).
  • Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.

  • Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:

    1. Report presence of signs and/or symptoms of bacterial conjunctivitis for less than or equal to (<=) 4 days prior to Visit 1
    2. Bulbar conjunctival injection: a grade of >= 1 on 0-4 scale of Bulbar Conjunctival Injection Scale
    3. Ocular conjunctival discharge: a grade of >= 1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale
  • Be willing to discontinue contact lens wear for the duration of the study.
  • Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the AAP Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker, 2016; American Academy of Pediatrics, 2016). The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator. If not done, child should be able to fixate on and follow a moving object, except participants < 2 months of age who have not yet developed this ability. Participants < 2 months will be enrolled at the discretion of investigator.
  • Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

Exclusion Criteria:

  • Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
  • Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
  • Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
  • Prior enrollment in a FST-100 or SHP640 clinical study.
  • Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
  • Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study.
  • Have a preplanned overnight hospitalization during the period of the study.
  • Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example [eg,] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis.
  • Have active or a history of ocular herpes.
  • Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-bacterial ocular infection (eg, viral, fungal, acanthamoebal, or other parasitic). Note: history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary.
  • Neonates or infants (ie, participants less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
  • Neonates or infants (ie, participants less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
  • Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
  • Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
  • Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma or be a glaucoma suspect.
  • Have any known clinically significant optic nerve defects.
  • Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
  • Presence of significant, active condition in the posterior segment that requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids) and may progress during the study participation period.
  • Have used any topical ocular or systemic antibiotics within <= 7 days of enrollment.
  • Have used any topical ocular non-steroidal anti-inflammatory drugs within <= 1 day of enrollment.
  • Have used any topical ophthalmic steroids in the last <= 14 days.
  • Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the periocular area.
  • Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1.
  • Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study.
  • Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes, or cystic fibrosis) that may affect the study parameters, per investigator's discretion.
  • Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone marrow transplantation.

  • Within 30 days prior to the first dose of investigational product:

    1. Have used an investigational product or device, or
    2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: SHP640
Participants will instill 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
Drug: SHP640
Instill 1 drop of SHP640 (povidone-iodine [PVPI] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
ACTIVE_COMPARATOR: PVP-I 0.6%
Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days
Drug: PVP-I 0.6%
Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
PLACEBO_COMPARATOR: Placebo
Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.
Drug: Placebo
Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
Time Frame: Day 5
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Day 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
Time Frame: Baseline, Day 5
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
Baseline, Day 5
Number of Participants With Clinical Resolution
Time Frame: Day 3, 8 and 12
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Day 3, 8 and 12
Number of Participants With Bacterial Eradication
Time Frame: Day 3, 8 and 12
Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.
Day 3, 8 and 12
Bulbar Conjunctival Injection Score
Time Frame: Day 3, 5, 8 and 12
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Day 3, 5, 8 and 12
Change From Baseline in the Bulbar Conjunctival Injection Score
Time Frame: Baseline, Day 3, 5, 8 and 12
Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
Baseline, Day 3, 5, 8 and 12
Ocular Conjunctival Discharge Score
Time Frame: Day 3, 5, 8 and 12
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Day 3, 5, 8 and 12
Change From Baseline in the Ocular Conjunctival Discharge Score
Time Frame: Baseline, Day 3, 5, 8 and 12
Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Baseline, Day 3, 5, 8 and 12
Global Clinical Score
Time Frame: Day 3, 5, 8 and 12
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Day 3, 5, 8 and 12
Change From Baseline in the Global Clinical Score
Time Frame: Baseline, Day 3, 5, 8 and 12
Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
Baseline, Day 3, 5, 8 and 12
Number of Participants With Modified Clinical Resolution
Time Frame: Day 3, 5, 8 and 12
Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Day 3, 5, 8 and 12
Number of Participants With Expanded Clinical Resolution
Time Frame: Day 3, 5, 8 and 12
Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
Day 3, 5, 8 and 12
Time to Clinical Resolution
Time Frame: Baseline to Day 12
Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.
Baseline to Day 12
Number of Participants Who Used Rescue Medication
Time Frame: Baseline to Day 12
Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.
Baseline to Day 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From start of study drug administration up to 14 days
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.
From start of study drug administration up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHP640-303
  • 2016-003361-25 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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