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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Blepharitis

Treatments: Drug: AzaSite®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00629980

041-105

P08651

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: AzaSite®

2

No Intervention group