Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis (DOUBle)

November 18, 2021 updated by: Sun Pharmaceutical Industries Limited

A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 Compared to AzaSite Alone, Dexamethasone Alone, and Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis

The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

917

Phase

  • 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

  • United States
    • Arizona
      • Chandler, Arizona, United States
        • Arizona Eye Center
      • Phoenix, Arizona, United States
        • Arizona Center for Clinical Trials LLC
      • Phoenix, Arizona, United States
        • Cornea Consultants of Arizona
    • California
      • Glendale, California, United States
        • Lugene Eye Institute
      • Inglewood, California, United States, 90301
        • United Medical Research Institute
      • Los Angeles, California, United States, 90048
        • Macy Eye Center
      • Mission Hills, California, United States
        • North Valley Eye Medical Group, Inc.
      • Newport Beach, California, United States
        • Eye Research Foundation
      • Petaluma, California, United States
        • North Bay Associates, Inc.
      • Rancho Cordova, California, United States, 95670
        • Martel Eye Medical Group
      • Redding, California, United States
        • Shasta Eye Medical Group, Inc.
      • San Diego, California, United States, 92123
        • San Diego Eye and Laser Center
      • San Diego, California, United States
        • West Coast Eye Care Associates
    • Florida
      • Boynton Beach, Florida, United States
        • Florida Eye Microsurgicial Institute, Inc.
      • Boynton Beach, Florida, United States
        • Zasa Clinical Research, LLC
      • Orlando, Florida, United States
        • Magruder Eye Institute
      • Palm Springs, Florida, United States
        • Vision Eye Care Center
      • Tampa, Florida, United States
        • International Research Center
    • Kentucky
      • Louisville, Kentucky, United States
        • Richard Eiferman, MD
    • Louisiana
      • Gretna, Louisiana, United States
        • Lakeview Optical
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Center for Sight, Inc.
    • Missouri
      • Kansas City, Missouri, United States
        • Tauber Eye Center
      • Saint Louis, Missouri, United States
        • Ophthalmology Associates
      • Washington, Missouri, United States
        • Comprehensive Eye Care Ltd
    • Nevada
      • Las Vegas, Nevada, United States
        • Abrams Eye Institute
      • Las Vegas, Nevada, United States
        • Nevada Eye Care Professionals
      • Sparks, Nevada, United States
        • Eye Care Associates of Nevada
    • New Jersey
      • Sewell, New Jersey, United States
        • David Ringel, OD PA
    • New York
      • Lynbrook, New York, United States
        • Ophthalmic Consultants of Long Island
      • Rockville Centre, New York, United States
        • Ophthalmic Consultants of Long Island
      • Valley Stream, New York, United States
        • Ophthalmic Consultants of Long Island
      • Wantagh, New York, United States
        • South Shore Eye Care
    • North Carolina
      • Charlotte, North Carolina, United States
        • Charlotte Eye Ear Nose & Throat Associates, P.A.
      • Charlotte, North Carolina, United States
        • Mundorf Eye Center
      • Winston-Salem, North Carolina, United States
        • James Branch, MD
    • Ohio
      • Cincinnati, Ohio, United States
        • Eye Care Associates of Greater Cincinnati, Inc.
      • Fairfield, Ohio, United States
        • Eye Care Associates of Greater Cincinnati, Inc.
      • Madeira, Ohio, United States
        • Eye Care Associates of Greater Cincinnati, Inc.
    • Oregon
      • Roseburg, Oregon, United States, 97471
        • Roseburg Research Associates, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Philadelphia Eye Associates
      • Wyomissing, Pennsylvania, United States
        • Research Across America @ Wyomissing Optometric Center Inc
    • Tennessee
      • Memphis, Tennessee, United States
        • Total Eye Care, PA
    • Texas
      • San Antonio, Texas, United States
        • David Shulman, MD
      • San Antonio, Texas, United States
        • Sun Research Institute
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Daynes Eye and Lasik

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
  • Signature of the subject or legally authorized representative on the Informed Consent Form.
  • Are willing and able to follow all instructions and attend all study visits.
  • Are willing to avoid disallowed medication for the duration of the study.
  • If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months.
  • Additional inclusion criteria also apply.

Exclusion Criteria:

  • Have known sensitivity or poor tolerance to any component of the Investigational Drug.
  • Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye.
  • Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters.
  • Have used any non-diagnostic topical ophthalmic solutions in the study eye.
  • Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test.
  • Currently suffer from alcohol and/or drug abuse.
  • Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device.
  • Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
  • Additional exclusion criteria also apply.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Other: Vehicle
Vehicle twice daily for 2 weeks
Active Comparator: Dexamethasone
Drug: Dexamethasone
Dexamethasone twice daily for 2 weeks
Experimental: ISV-502
Drug: ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Azithromycin and Dexamethasone twice daily for 2 weeks
Other Names:
  • AzaSite Plus
Active Comparator: AzaSite
Drug: Azasite
Azasite twice daily for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Resolution
Time Frame: Day 15
The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
Day 15
Recurrence of Clinical Signs and Symptoms
Time Frame: 6 Month
The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
6 Month

Collaborators and Investigators

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

Sponsor

Sun Pharmaceutical Industries Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-10-502-004

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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