A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)

Stopped early · Phase 2

Conditions studied: Posterior Blepharoconjunctivitis

In brief

One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.

Key facts

Study ID

NCT01220258

Run by

Merck Sharp & Dohme LLC

People needed

29

Starts

2010-11-01

Expected to finish

2011-08-01

Last updated by the study team

2013-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Have a current diagnosis of posterior blepharoconjunctivitis in both eyes
• (except for healthy volunteers)
• Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR
• If female, are non-pregnant or non-lactating

You may not qualify if…

• Have anterior blepharitis
• Have lid structural abnormalities
• Have had penetrating intraocular surgery in the past 90 days or require
• penetrating intraocular surgery during the study
• Unable to withhold the use of contact lenses within 3 days prior to Visit 1
• during the study
• Have been diagnosed with ongoing glaucoma
• Have a serious medical condition which could confound study assessments

Where it is running

• Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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