Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo

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 PVP-Iodine and Placebo in the Treatment of Adenoviral 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 adenoviral conjunctivitis.

Study Overview

• Status: Terminated
• Conditions: Adenoviral Conjunctivitis
• Intervention / Treatment: Drug: SHP640; Drug: PVP-I 0.6%; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Sippy Downs, Queensland, Australia, 4556
      • University of the Sunshine Coast Clinical Trials Centre
• Austria
  • Linz, Austria, 4020
    • Kepler Universitätsklinikum
  • 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
  • Quebec
    • Montreal, Quebec, Canada, H4A 3S5
      • McGill University Health Centre/Glen Site / Royal Victoria Hospital
• Estonia
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 10120
    • Eye Clinic Dr Kirsta Turman
  • Tartu, Estonia, 51010
    • Tartu University Hospital
• France
  • Paris, France, 75015
    • Hôpital Necker - Enfants malades
  • Haute Vienne
    • Limoges, Haute Vienne, France, 87042
      • CHU Limoges - Hôpital Dupuytren
• Germany
  • Mainz, Germany, 55131
    • Klinisches Studienzentrum der Augenklinik
  • Muenster, Germany, 48145
    • Augenärzte am Franziskus Hospital
• Hungary
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem
  • Kaposvár, Hungary, 7400
    • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Veszprem, Hungary, 8200
    • Csolnoky Ferenc Korhaz
  • Csongrad
    • Szeged, Csongrad, Hungary, 6720
      • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Heves
    • Gyongyos, Heves, Hungary, 3200
      • Bugat Pal Korhaz
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500034
      • L. V. Prasad Eye Institute
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • M. S. Ramaiah Medical College And Hospital
    • Bangalore, Karnataka, India, 560037
      • Sankara Eye Hospital
    • Bangalore, Karnataka, India, 560052
      • Bhagwan Mahaveer Jain Hospital
    • Bangalore, Karnataka, India, 560090
      • Sapthagiri Hospital
    • Belgaum, Karnataka, India, 590010
      • K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
  • Maharashtra
    • Nagpur, Maharashtra, India, 440025
      • NKP Salve Institute of Medical Sciences
    • Navi Mumbai, Maharashtra, India, 400706
      • Dr. D. Y. Patil Medical College
    • Pune, Maharashtra, India, 411060
      • PBMA'S H. V. Desai Eye Hospital
  • Rajasthan
    • Bikaner, Rajasthan, India, 334003
      • S. P. Medical College & Associated Group of Hospitals
  • Uttar Pradesh
    • Noida, Uttar Pradesh, India, 201301
      • ICARE Eye Hospital and Post Graduate Institute
  • West Bengal
    • Kolkata, West Bengal, India, 700073
      • Regional Institute of Ophthalmology
• Israel
  • Afula, Israel, 18341
    • Haemek Medical Center
  • Beer Sheva, Israel, 84101
    • Soroka University Medical Center
  • Haifa, Israel, 3109601
    • Rambam MC
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center-Beilinson Campus
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bologna, Italy, 40138
    • A.O.U. Policlinico San'Orsola-Malpighi
• Peru
  • La Libertad, Peru, 13007
    • Instituto Regional de Oftalmología
  • Lima, Peru, 27
    • Macula D&T S.R.L.
  • Lima, Peru, 27
    • Oftalmosalud SRL.
• Poland
  • Bytom, Poland, 41-902
    • Szpital Specjalistyczny Nr 1
  • Krakow, Poland, 31-070
    • Centrum Medyczne UNO-MED
  • Olsztyn, Poland, 10-424
    • Centrum Diagnostyki i Mikrochirurgii Oka LENS
  • Tarnów, Poland, 33-100
    • Centrum Medyczne Uno-Med (Private Practice)
  • Warszawa, Poland, 01 -364
    • Retina Sp. z o.o.
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2113
      • Newtown Clinical Research
    • Pretoria, Gauteng, South Africa, 0181
      • Into Research
    • Pretoria, Gauteng, South Africa, 83
      • Pretoria Eye Institute Research Foundation
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4001
      • Nelson R Mandela School of Medicine Ophthalmology Department
• Spain
  • Burgos, Spain, 9006
    • Complejo Asistencial Universitario de Burgos
  • Girona, Spain, 17001
    • Hospital Universitari de Girona Dr Josep Trueta
  • Huelva, Spain, 21002
    • Clinica Oftalmologia Gil Piña
  • Madrid, Spain, 28010
    • Clínica Rementería
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Sevilla, Spain, 41092
    • Cartuja Vision
  • Valencia, Spain, 46015
    • FISABIO-Oftalmología Médica
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Asturias
    • Oviedo, Asturias, Spain, 33012
      • Instituto Oftalmologico Fernandez-Vega
• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M139WL
      • Manchester Royal Eye Hospital
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center
    • Glendale, Arizona, United States, 85308
      • Midwestern University Eye Institute
    • Prescott, Arizona, United States, 86301
      • M&M Eye Institute
    • Sun City, Arizona, United States, 85351
      • Walman Eye Center
  • California
    • Azusa, California, United States, 91702
      • Milton M. Hom, OD, FAAO
    • Glendora, California, United States, 91741
      • Mark B. Kislinger, MD, PhD, Inc.
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Irvine, California, United States, 92604
      • Lakeside Vision Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University
    • Long Beach, California, United States, 90808
      • Eye Physicians of Long Beach
    • Los Angeles, California, United States, 90048
      • Macy Eye Center
    • Los Angeles, California, United States, 90020
      • Oxford Optical
    • Northridge, California, United States, 91325
      • Shultz Chang Vision
    • Palo Alto, California, United States, 94303
      • Stanford Byers Eye Institute
    • 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, 96002
      • Shasta Eye Medical Group, Inc.
  • Florida
    • Bradenton, Florida, United States, 34209
      • The Eye Associates
    • Fort Lauderdale, Florida, United States, 33309
      • South Florida Vision Associates, LLC
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute
    • Miami, Florida, United States, 33166
      • Lorites Medical Group
    • Orlando, Florida, United States, 32825
      • Pediatric & Adult Research Center, LLC
    • Stuart, Florida, United States, 34494
      • East Florida Eye Institute
    • Tamarac, Florida, United States, 33321
      • Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Eye Care Centers Management, Inc.
  • Illinois
    • 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, an AMR affiliate
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Kentucky Eye Institute
    • Lexington, Kentucky, United States, 40509
      • Koffler Vision Group
    • Louisville, Kentucky, United States, 40220
      • Senior Health Services
    • Paducah, Kentucky, United States, 42001
      • Baker, Carl W
  • Louisiana
    • Gretna, Louisiana, United States, 70056
      • Lakeview Vision - Gretna
    • West Monroe, Louisiana, United States, 71291
      • Haik Humble Eye Center
  • Maine
    • Bangor, Maine, United States, 04401
      • Eye Center Northeast
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary
    • Lexington, Massachusetts, United States, 02421
      • Shire Call Center
    • Winchester, Massachusetts, United States, 02114
      • Clinical Eye Research of Boston
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • The Regents of the University of Michigan
  • 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
    • Springfield, Missouri, United States, 65806
      • Mercy Research
  • Nevada
    • Las Vegas, Nevada, United States, 89129
      • Nevada Eye Care Professionals
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
    • South Orange, New Jersey, United States, 07079
      • Northern New Jersey Eye Institute
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • Oculus Research
    • Winston-Salem, North Carolina, United States, 27101
      • James Branch, M.D.
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18902
      • Matossian Eye Associates
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Eye Center
    • Wyomissing, Pennsylvania, United States, 19610
      • Wyomissing Optometric Center
  • 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, 38104
      • The Eye Center at Southern College of Optometry
    • Memphis, Tennessee, United States, 38120
      • Eye Specialty Group
    • Nashville, Tennessee, United States, 37205
      • Nashville Vision Associates
    • Nashville, Tennessee, United States, 37215
      • Toyos Clinic
  • Texas
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
    • Lakeway, Texas, United States, 78734
      • Lake Travis Eye & Laser Center
    • League City, Texas, United States, 77573
      • Houston Eye Associates
    • Mission, Texas, United States, 78572
      • DCT-Shah Research, LLC dba Discovery Clinical Trials
    • 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
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • Emerson Clinical Research Institute, LLC
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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 lesser than (<) 3 months of age at Visit 1 must have been full-term, i.e. greater than or equal to (>=) 37 weeks gestational age at birth).

• Meet at least 1 of the 2 criteria below:

  a) Have a positive AdenoPlus test at Visit 1 in at least 1 eye. b) Have at least 2 of the following 5 criteria, based upon medical history and examination: i.Symptoms within the past 7 days consistent with acute upper respiratory tract infection (eg. sore throat, cough, rhinorrhea, etc).

ii. Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis iii. Acute onset within the past 4 days of one or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity.

iv. Enlarged periauricular lymph node(s). v. Presence of follicles on tarsal conjunctiva. Note:If the participant only meets Inclusion Criterion (a positive AdenoPlus test in at least 1 eye), then the same eye must meet the mentioned below Inclusion Criterion.

• Have a clinical diagnosis of suspected adenoviral 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 adenoviral conjunctivitis for lesser than or equal to (<=) 4 days prior to Visit 1
  2. Bulbar conjunctival injection: a grade of >= 1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale.
  3. Watery conjunctival discharge: a grade of >= 1 (mild) on a 0-3 Watery 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 the 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 participants 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 pre-planned overnight hospitalization during the period of the study.
• Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
• Have presence of corneal subepithelial infiltrates at Visit 1.
• Have active or 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-adenoviral ocular infection (e.g. bacterial, 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 (i.e. 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 (i.e. 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 (e.g. 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 which requires invasive treatment (e.g. intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period.
• Have used any topical ocular or systemic anti-vials or antibiotics within <= 7 days of enrollment.
• Have used any topical ocular Non-steroidal Anti-inflammataory Drugs (NSAIDs) 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 peri-ocular 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 the 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 (antihepatitis 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHP640; Participants will receive one drop of SHP640 (0.1 percent [%] dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.	Drug: SHP640; Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.; Other Names: FST-100
Active Comparator: PVP-I 0.6%; Participants will receive one drop of 0.6% PVP-I ophthalmic solution in each eye QID for 7 days.	Drug: PVP-I 0.6%; Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
Placebo Comparator: Placebo; Participants will receive one drop of placebo ophthalmic solution in each eye QID for 7 days.	Other: Placebo; Participants will receive one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 6	Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.	Day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Resolution Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6	Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.	Day 6
Number of Participants With Clinical Resolution Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 6	Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.	Day 6
Number of Participants With Adenoviral Eradication Among Who Received Povidone-Iodine (PVP-I) or Placebo on Day 3	Adenoviral eradication for the study eye was defined as negative Cell Culture- Immunofluorescence Assay (CC-IFA) in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in PVP-I 0.6% and placebo reporting groups only but not in SHP640.	Day 3
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Placebo on Day 6	Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.	Day 6
Number of Participants With Adenoviral Eradication Among Who Received SHP640 or Povidone-Iodine (PVP-I) on Day 6	Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Data analysis was performed in SHP640 and PVP-I 0.6% reporting groups only but not in placebo.	Day 6
Percent Change From Baseline in Adenovirus Viral Titer as Assessed by Quantitative Polymerase Chain Reaction (qPCR) at Day 6 and 8	qPCR test was performed on all CC-IFA positive samples at all visits to determine viral count in the study eye. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Percent (%) change from baseline in adenovirus viral titer as assessed by qPCR was reported.	Day 6 and 8
Number of Participants With Adenoviral Eradication on Day 8 and 12/Early Termination (ET)	Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.	Day 8 and 12/ET
Number of Participants With Clinical Resolution on on Day 3, 8 and 12/Early Termination (ET)	Clinical resolution of adenoviral conjunctivitis was defined as the absence (score=0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represent worse symptoms for both scores.	Day 3, 8 and 12/ET
Change From Baseline in Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)	The Individual clinical signs score (bulbar conjunctival injection and watery conjunctival discharge) in the study were reported. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CCIFA results at baseline.	Day 3, 6, 8 and 12/ET
Number of Participants With at Least 2 Point Reduction From Baseline in the Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)	Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.	Day 3, 6, 8 and 12/ET
Number of Participants With Modified Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)	Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eyewas defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.	Day 3, 6, 8 and 12/ET
Number of Participants With Expanded Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)	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 the sum of bulbar conjunctival injection and watery conjunctival discharge. The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores at baseline as well as his/her CC-IFA results at baseline.	Day 3, 6, 8 and 12/ET
Number of Participants With Status of Cross-over Infection on Day 3, 6, 8 and 12/Early Termination (ET)	Number of participants with status of cross-over infection to a participant's fellow eye. Participants with only 1 infected eye at baseline were reported.	Day 3, 6, 8 and 12/ET
Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)	Time to clinical resolution were reported based on the assessments in the study eye.	Day 3, 6, 8 and 12/ET
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) of SHP640	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. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Any AE that occured after the first dose of IP instillation was considered a TEAE.	From start of the study up to Day 14

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): May 13, 2019
• Study Completion (Actual): May 13, 2019

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Chlamydiaceae Infections; Eye Infections, Bacterial; Eye Infections; Chlamydia Infections; Conjunctivitis, Bacterial; Conjunctivitis; Conjunctivitis, Inclusion
• Other Study ID Numbers: SHP640-301; 2016-002439-14 (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; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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