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

Phase 2

Terminated

• Conditions: Blepharitis
• Interventions: Drug: Azithromycin ophthalmic solution, 1%; Drug: Vehicle

• Registration Number: NCT01269658
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Disposition First Submitted: 2011-07-06
• Disposition First Submitted QC: 2011-07-06
• Disposition First Posted: 2011-07-14
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin ophthalmic solution, 1%	Azithromycin ophthalmic solution, 1%	-
Vehicle	Vehicle	-

Primary Outcome Measures

Name	Time	Method
Resolution of clinical signs of blepharitis	Day 28

Secondary Outcome Measures

Name	Time	Method
Time to first clinical resolution	Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from baseline for clinical signs of blepharitis	Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from end of dosing for clinical signs of blepharitis	Days 42, 56, 70, and 84
Response to the Blepharitis Symptoms Questionnaire (BSQ)	Days 1, 7, 14, 21, 28, 42, 56, 70, and 84