Status:
COMPLETED
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Blepharitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT00894530
Start Date
May 1 2009
End Date
December 1 2009
Last Update
November 21 2013
Active Locations (26)
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1
Schwartz Laser Eye Center
Scottsdale, Arizona, United States, 85260
2
McDonald Eye Associates
Fayetteville, Arkansas, United States, 72703
3
Sall Research Medical Center, Inc.
Artesia, California, United States, 90701
4
Sall Research Medical Center
Artesia, California, United States, 90701