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

Primary Purpose

Blepharitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Azasite
Dexamethasone
Vehicle
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Eye Center
  • Arizona Center for Clinical Trials LLC
  • Cornea Consultants of Arizona
  • Lugene Eye Institute
  • United Medical Research Institute
  • Macy Eye Center
  • North Valley Eye Medical Group, Inc.
  • Eye Research Foundation
  • North Bay Associates, Inc.
  • Martel Eye Medical Group
  • Shasta Eye Medical Group, Inc.
  • San Diego Eye and Laser Center
  • West Coast Eye Care Associates
  • Florida Eye Microsurgicial Institute, Inc.
  • ZASA Clinical Research, LLC
  • Magruder Eye Institute
  • Vision Eye Care Center
  • International Research Center
  • Richard Eiferman, MD
  • Lakeview Optical
  • Center for Sight, Inc.
  • Tauber Eye Center
  • Ophthalmology Associates
  • Comprehensive Eye Care Ltd
  • Abrams Eye Institute
  • Nevada Eye Care Professionals
  • Eye Care Associates of Nevada
  • David Ringel, OD PA
  • Ophthalmic Consultants of Long Island
  • Ophthalmic Consultants of Long Island
  • Ophthalmic Consultants of Long Island
  • South Shore Eye Care
  • Charlotte Eye Ear Nose & Throat Associates, P.A.
  • Mundorf Eye Center
  • James Branch, MD
  • Eye Care Associates of Greater Cincinnati, Inc.
  • Eye Care Associates of Greater Cincinnati, Inc.
  • Eye Care Associates of Greater Cincinnati, Inc.
  • Roseburg Research Associates, LLC
  • Philadelphia Eye Associates
  • Research Across America @ Wyomissing Optometric Center Inc
  • Total Eye Care, PA
  • David Shulman, MD
  • Sun Research Institute
  • Daynes Eye and Lasik

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

ISV-502

AzaSite

Dexamethasone

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 1, 2011
Last Updated
November 18, 2021
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01408082
Brief Title
Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
Acronym
DOUBle
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
917 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ISV-502
Arm Type
Experimental
Arm Title
AzaSite
Arm Type
Active Comparator
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Other Intervention Name(s)
AzaSite Plus
Intervention Description
Azithromycin and Dexamethasone twice daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Azasite
Intervention Description
Azasite twice daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone twice daily for 2 weeks
Intervention Type
Other
Intervention Name(s)
Vehicle
Intervention Description
Vehicle twice daily for 2 weeks
Primary Outcome Measure Information:
Title
Clinical Resolution
Description
The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
Time Frame
Day 15
Title
Recurrence of Clinical Signs and Symptoms
Description
The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
Time Frame
6 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
Country
United States
Facility Name
Arizona Center for Clinical Trials LLC
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Cornea Consultants of Arizona
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
Country
United States
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Macy Eye Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
North Valley Eye Medical Group, Inc.
City
Mission Hills
State/Province
California
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
Country
United States
Facility Name
North Bay Associates, Inc.
City
Petaluma
State/Province
California
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Shasta Eye Medical Group, Inc.
City
Redding
State/Province
California
Country
United States
Facility Name
San Diego Eye and Laser Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
West Coast Eye Care Associates
City
San Diego
State/Province
California
Country
United States
Facility Name
Florida Eye Microsurgicial Institute, Inc.
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
ZASA Clinical Research, LLC
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Magruder Eye Institute
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Vision Eye Care Center
City
Palm Springs
State/Province
Florida
Country
United States
Facility Name
International Research Center
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Richard Eiferman, MD
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Lakeview Optical
City
Gretna
State/Province
Louisiana
Country
United States
Facility Name
Center for Sight, Inc.
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Comprehensive Eye Care Ltd
City
Washington
State/Province
Missouri
Country
United States
Facility Name
Abrams Eye Institute
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Nevada Eye Care Professionals
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Eye Care Associates of Nevada
City
Sparks
State/Province
Nevada
Country
United States
Facility Name
David Ringel, OD PA
City
Sewell
State/Province
New Jersey
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Valley Stream
State/Province
New York
Country
United States
Facility Name
South Shore Eye Care
City
Wantagh
State/Province
New York
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates, P.A.
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Mundorf Eye Center
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
James Branch, MD
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Eye Care Associates of Greater Cincinnati, Inc.
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Eye Care Associates of Greater Cincinnati, Inc.
City
Fairfield
State/Province
Ohio
Country
United States
Facility Name
Eye Care Associates of Greater Cincinnati, Inc.
City
Madeira
State/Province
Ohio
Country
United States
Facility Name
Roseburg Research Associates, LLC
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97471
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Across America @ Wyomissing Optometric Center Inc
City
Wyomissing
State/Province
Pennsylvania
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
David Shulman, MD
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Daynes Eye and Lasik
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29325546
Citation
Hosseini K, Bourque LB, Hays RD. Development and evaluation of a measure of patient-reported symptoms of Blepharitis. Health Qual Life Outcomes. 2018 Jan 11;16(1):11. doi: 10.1186/s12955-018-0839-5.
Results Reference
derived

Learn more about this trial

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

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