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

Blepharitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408082
• Other study ID #: C-10-502-004
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 917
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Azithromycin and Dexamethasone twice daily for 2 weeks
• Azasite
Azasite twice daily for 2 weeks
• Dexamethasone
Dexamethasone twice daily for 2 weeks

Other:
• Vehicle
Vehicle twice daily for 2 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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