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

A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis

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.

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