Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis

A Multi-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone in Subjects With Blepharitis

The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.

Inclusion Criteria:

• diagnosis of moderate to severe chronic blepharitis
• if female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

• had ocular surface surgery (LASIK, refractive, etc.) within the past year
• unwilling to discontinue the use of contact lenses during the study
• have glaucoma
• unable or unwilling to withhold the use of lid scrubs during the study
• have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
• currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation