The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)

Blepharitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894530
• Other study ID #: P08638
• Secondary ID: 044-102
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2009
• Last updated: October 29, 2013
• Start date: May 2009
• Est. completion date: December 2009

Study information

• Verified date: October 2013
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have best corrected visual acuity in both eyes of at least +0.7 or better

• If female, are non-pregnant or non-lactating

• Have a current diagnosis of blepharitis in one or both eyes

Exclusion Criteria:

• Have lid structural abnormalities

• Have suspected ocular fungal or viral infection

• Have practiced warm compress therapy within 14 days prior to Visit 2

• Unable to withhold the use of contact lenses during the treatment or follow-up periods

• Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits

• Have had penetrating intraocular surgery within 90 days prior to Visit 2

• Have had ocular surface surgery within the past year prior to Visit 2

• Have a serious medical condition which could confound study assessments

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• Azithromycin ophthalmic solution, 1%
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
• Placebo
One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days

Locations

Country	Name	City	State
United States	Sall Research Medical Center	Artesia	California
United States	Sall Research Medical Center, Inc.	Artesia	California
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Wohl Eye Center	Bloomingdale	Illinois
United States	Hernando Eye Institute	Brooksville	Florida
United States	Columbus Ophthalmology Associates	Columbus	Ohio
United States	Ohio State University - College of Optometry	Columbus	Ohio
United States	Park Ophthalmology	Durham	North Carolina
United States	McDonald Eye Associates	Fayetteville	Arkansas
United States	United Medical Research Company	Inglewood	California
United States	Taustine Eye Center	Louisville	Kentucky
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Center for Excellence in Eye Care	Miami	Florida
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Coastal Vision Medical Group	Newport Beach	California
United States	Philadelphia Eye Associates	Philadelphia	Pennsylvania
United States	Eye Clinics of South Texas	San Antonio	Texas
United States	West Coast Eye Care	San Diego	California
United States	Schwartz Laser Eye Center	Scottsdale	Arizona
United States	David M. Ringel, DO, PA	Sewell	New Jersey
United States	Ophthalmology Associates	St Louis	Missouri
United States	Thomas John Vision Institute	Tinley Park	Illinois
United States	Comprehensive Eye Care Ltd	Washington	Missouri
United States	Brar-Parekh Eye Associates	West Paterson	New Jersey
United States	Grene Vision Group	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eyelid margin erythema		Four weeks	No
Secondary	Signs and symptoms of Blepharitis		One week, two weeks, three weeks, four weeks, six weeks, eight weeks	No