A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)

Phase 2

Terminated

• Conditions: Posterior Blepharoconjunctivitis
• Interventions: Drug: Azithromycin ophthalmic solution, 1%

• Registration Number: NCT01220258
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Study Start: 2010-11
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Have a current diagnosis of posterior blepharoconjunctivitis in both eyes

(except for healthy volunteers)

• Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR
• If female, are non-pregnant or non-lactating

Exclusion Criteria

• Have anterior blepharitis
• Have lid structural abnormalities
• Have had penetrating intraocular surgery in the past 90 days or require

penetrating intraocular surgery during the study

• Unable to withhold the use of contact lenses within 3 days prior to Visit 1

during the study

• Have been diagnosed with ongoing glaucoma
• 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%	-

Primary Outcome Measures

Name	Time	Method
Change from baseline of investigator-rated scores for eyelid margin erythema	Week 4

Secondary Outcome Measures

Name	Time	Method
Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms	Weeks 2, 4, 6, 8
Change from baseline of investigator-rated scores of blepharoconjunctivitis signs	Weeks 2, 4, 6, 8

Trial Locations

Locations (1)

Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine; 🇺🇸 Houston, Texas, United States