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

Phase 2TerminatedNCT01220258

Merck Sharp & Dohme LLC29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Posterior Blepharoconjunctivitis

Interventions

Azithromycin ophthalmic solution, 1%DRUG

1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine

Houston, Texas, United States

Outcomes

Primary Outcomes

Change from baseline of investigator-rated scores for eyelid margin erythema

Time frame: Week 4

Secondary Outcomes

Change from baseline of investigator-rated scores of blepharoconjunctivitis signs

Time frame: Weeks 2, 4, 6, 8

Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms

Time frame: Weeks 2, 4, 6, 8

Data from ClinicalTrials.gov

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