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

October 29, 2013 updated by: Merck Sharp & Dohme LLC

A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis

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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
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)
Experimental: 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
Resolution of clinical signs of blepharitis
Time Frame: Day 28
Day 28

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Charles Johnson, MBChB, Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 21, 2010

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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