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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
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

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
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
GroupInterventionDescription
1Azithromycin ophthalmic solution, 1%-
2Placebo-
Primary Outcome Measures
NameTimeMethod
Eyelid margin erythemaFour weeks
Secondary Outcome Measures
NameTimeMethod
Signs and symptoms of BlepharitisOne week, two weeks, three weeks, four weeks, six weeks, eight weeks

Trial Locations

Locations (26)

Schwartz Laser Eye Center

🇺🇸

Scottsdale, Arizona, United States

McDonald Eye Associates

🇺🇸

Fayetteville, Arkansas, United States

Sall Research Medical Center, Inc.

🇺🇸

Artesia, California, United States

Sall Research Medical Center

🇺🇸

Artesia, California, United States

United Medical Research Company

🇺🇸

Inglewood, California, United States

North Valley Eye Medical Group

🇺🇸

Mission Hills, California, United States

Coastal Vision Medical Group

🇺🇸

Newport Beach, California, United States

West Coast Eye Care

🇺🇸

San Diego, California, United States

Hernando Eye Institute

🇺🇸

Brooksville, Florida, United States

Center for Excellence in Eye Care

🇺🇸

Miami, Florida, United States

Scroll for more (16 remaining)
Schwartz Laser Eye Center
🇺🇸Scottsdale, Arizona, United States

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