Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
DOUBle
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
1 other identifier
interventional
917
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2011
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 3, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedNovember 19, 2021
November 1, 2021
1.4 years
August 1, 2011
November 18, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
6 Month
Study Arms (4)
ISV-502
EXPERIMENTALAzaSite
ACTIVE COMPARATORDexamethasone
ACTIVE COMPARATORVehicle
PLACEBO COMPARATORInterventions
Azithromycin and Dexamethasone twice daily for 2 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Arizona Eye Center
Chandler, Arizona, United States
Arizona Center for Clinical Trials LLC
Phoenix, Arizona, United States
Cornea Consultants of Arizona
Phoenix, Arizona, United States
Lugene Eye Institute
Glendale, California, United States
United Medical Research Institute
Inglewood, California, 90301, United States
Macy Eye Center
Los Angeles, California, 90048, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Associates, Inc.
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, 95670, United States
Shasta Eye Medical Group, Inc.
Redding, California, United States
San Diego Eye and Laser Center
San Diego, California, 92123, United States
West Coast Eye Care Associates
San Diego, California, United States
Florida Eye Microsurgicial Institute, Inc.
Boynton Beach, Florida, United States
ZASA Clinical Research, LLC
Boynton Beach, Florida, United States
Magruder Eye Institute
Orlando, Florida, United States
Vision Eye Care Center
Palm Springs, Florida, United States
International Research Center
Tampa, Florida, United States
Richard Eiferman, MD
Louisville, Kentucky, United States
Lakeview Optical
Gretna, Louisiana, United States
Center for Sight, Inc.
Fall River, Massachusetts, 02720, United States
Tauber Eye Center
Kansas City, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Comprehensive Eye Care Ltd
Washington, Missouri, United States
Abrams Eye Institute
Las Vegas, Nevada, United States
Nevada Eye Care Professionals
Las Vegas, Nevada, United States
Eye Care Associates of Nevada
Sparks, Nevada, United States
David Ringel, OD PA
Sewell, New Jersey, United States
Ophthalmic Consultants of Long Island
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
South Shore Eye Care
Wantagh, New York, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Charlotte, North Carolina, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
James Branch, MD
Winston-Salem, North Carolina, United States
Eye Care Associates of Greater Cincinnati, Inc.
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
Roseburg Research Associates, LLC
Roseburg, Oregon, 97471, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
Research Across America @ Wyomissing Optometric Center Inc
Wyomissing, Pennsylvania, United States
Total Eye Care, PA
Memphis, Tennessee, United States
David Shulman, MD
San Antonio, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Daynes Eye and Lasik
Salt Lake City, Utah, 84103, United States
Related Publications (1)
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.
PMID: 29325546DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2011
First Posted
August 3, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
November 19, 2021
Record last verified: 2021-11