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

Phase 2

Completed

• Conditions: Blepharitis
• Interventions: Drug: Azithromycin ophthalmic solution, 1%; Drug: Placebo

• Registration Number: NCT00894530
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-07
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Disposition First Submitted: 2010-10-29
• Disposition First Submitted QC: 2010-10-29
• Disposition First Posted: 2010-11-02
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Azithromycin ophthalmic solution, 1%	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Eyelid margin erythema	Four weeks

Secondary Outcome Measures

Name	Time	Method
Signs and symptoms of Blepharitis	One week, two weeks, three weeks, four weeks, six weeks, eight weeks

Trial Locations

Locations (26)

Schwartz Laser Eye Center; 🇺🇸 Scottsdale, Arizona, United States

Eastern Maine Medical Center; 🇺🇸 Bangor, Maine, United States

Total Eye Care, PA; 🇺🇸 Memphis, Tennessee, United States

Grene Vision Group; 🇺🇸 Wichita, Kansas, United States

Eye Clinics of South Texas; 🇺🇸 San Antonio, Texas, United States

Coastal Vision Medical Group; 🇺🇸 Newport Beach, California, United States

Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Hernando Eye Institute; 🇺🇸 Brooksville, Florida, United States

Wohl Eye Center; 🇺🇸 Bloomingdale, Illinois, United States

Thomas John Vision Institute; 🇺🇸 Tinley Park, Illinois, United States

Ohio State University - College of Optometry; 🇺🇸 Columbus, Ohio, United States

David M. Ringel, DO, PA; 🇺🇸 Sewell, New Jersey, United States

Taustine Eye Center; 🇺🇸 Louisville, Kentucky, United States

Ophthalmology Associates; 🇺🇸 St Louis, Missouri, United States

Philadelphia Eye Associates; 🇺🇸 Philadelphia, Pennsylvania, United States

Sall Research Medical Center, Inc.; 🇺🇸 Artesia, California, United States

McDonald Eye Associates; 🇺🇸 Fayetteville, Arkansas, United States

United Medical Research Company; 🇺🇸 Inglewood, California, United States

North Valley Eye Medical Group; 🇺🇸 Mission Hills, California, United States

Park Ophthalmology; 🇺🇸 Durham, North Carolina, United States

Brar-Parekh Eye Associates; 🇺🇸 West Paterson, New Jersey, United States

Columbus Ophthalmology Associates; 🇺🇸 Columbus, Ohio, United States

Sall Research Medical Center; 🇺🇸 Artesia, California, United States

West Coast Eye Care; 🇺🇸 San Diego, California, United States

Ophthalmic Consultants of Long Island; 🇺🇸 Lynbrook, New York, United States

Comprehensive Eye Care Ltd; 🇺🇸 Washington, Missouri, United States