A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Azithromycin; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Have a current diagnosis of blepharitis

• Have a best corrected visual acuity (BCVA), using corrective lenses if

necessary, in both eyes of at least +0.7

• If female, are non-pregnant or non-lactating

Exclusion Criteria:

• Have a concurrent acute hordeolum (stye) or chalazion

• Have inflammation of the ocular surface

• Have used artificial tears within 48 hours prior to Visit 1 or anticipate

using during the study

• Have had ocular surgery in the past 90 days or will require it during the

study

• Unable to withhold the use of contact lenses during the study

• Have a known hypersensitivity to azithromycin, erythromycin, any other

macrolide antibiotic, or any of the other ingredients in the study

medication

• Have been diagnosed with ongoing glaucoma

• Unable to withhold the use of ocular cosmetic products within 48 hours

prior to Visit 1 and throughout the study

• Have a serious medical condition which could confound study assessments