Clinical trial NCT00894530: The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blepharitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Eyelid margin erythema
timeFrame: Four weeks
Secondary outcomes:
measure: Signs and symptoms of Blepharitis
timeFrame: One week, two weeks, three weeks, four weeks, six weeks, eight weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Fayetteville
country: United States
facility: McDonald Eye Associates
state: Arkansas
city: Artesia
country: United States
facility: Sall Research Medical Center, Inc.
state: California
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Inglewood
country: United States
facility: United Medical Research Company
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: Coastal Vision Medical Group
state: California
city: San Diego
country: United States
facility: West Coast Eye Care
state: California
city: Brooksville
country: United States
facility: Hernando Eye Institute
state: Florida
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Bloomingdale
country: United States
facility: Wohl Eye Center
state: Illinois
city: Tinley Park
country: United States
facility: Thomas John Vision Institute
state: Illinois
city: Wichita
country: United States
facility: Grene Vision Group
state: Kansas
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: St Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care Ltd
state: Missouri
city: Sewell
country: United States
facility: David M. Ringel, DO, PA
state: New Jersey
city: West Paterson
country: United States
facility: Brar-Parekh Eye Associates
state: New Jersey
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Durham
country: United States
facility: Park Ophthalmology
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University - College of Optometry
state: Ohio
city: Columbus
country: United States
facility: Columbus Ophthalmology Associates
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: San Antonio
country: United States
facility: Eye Clinics of South Texas
state: Texas
Study officials:
affiliation: Medical Monitor, Inspire
name: Reza Haque, MD,PhD
role: STUDY_CHAIR
References: