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

A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks

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 Overview

• Status: Terminated
• Conditions: Posterior Blepharoconjunctivitis
• Intervention / Treatment: Drug: Azithromycin ophthalmic solution, 1%

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azithromycin ophthalmic solution, 1%	Drug: Azithromycin ophthalmic solution, 1%; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline of investigator-rated scores for eyelid margin erythema	Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline of investigator-rated scores of blepharoconjunctivitis signs	Weeks 2, 4, 6, 8
Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms	Weeks 2, 4, 6, 8

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): December 16, 2013
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis; Anti-Infective Agents; Anti-Bacterial Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Azithromycin
• Other Study ID Numbers: P08641; 041-118