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

Phase 2

Completed

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

• Registration Number: NCT00892970
• 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 two-week treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Disposition First Submitted: 2010-10-29
• Disposition First Submitted QC: 2010-10-29
• Disposition First Posted: 2010-11-02
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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

• 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	Two weeks

Secondary Outcome Measures

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

Trial Locations

Locations (33)

Jones Eye Institute; 🇺🇸 Little Rock, Arkansas, United States

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

Milton Hom, OD; 🇺🇸 Azusa, California, United States

The Jules Stein Eye Institute UCLA Laser Refractive Center; 🇺🇸 Los Angeles, California, United States

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

David Wirta, MD, Inc.; 🇺🇸 Newport Beach, California, United States

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

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

Wolstan Eye Associates; 🇺🇸 Torrence, California, United States

Eye Center - A Medical and Surgical Group; 🇺🇸 Hamden, Connecticut, United States

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