The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638) | NCT00894530 | Trialant
CompletedInterventionalPhase 2Updated Nov 21, 2013
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
ClinicalTrials.gov ID
NCT00894530
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
314Actual
Last Update Posted
Nov 21, 2013Estimated
Start Date
May 2009
Primary Completion Date
Dec 2009Actual
Completion Date
Dec 2009Actual
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.
Blepharitis
Azithromycin ophthalmic solution, 1%
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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