The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)

The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.

Study Overview

• Status: Completed
• Conditions: Blepharitis
• Intervention / Treatment: Drug: Azithromycin ophthalmic solution, 1%; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Schwartz Laser Eye Center
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • McDonald Eye Associates
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Artesia, California, United States, 90701
      • Sall Research Medical Center, Inc.
    • Inglewood, California, United States, 90301
      • United Medical Research Company
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group
    • Newport Beach, California, United States, 92660
      • Coastal Vision Medical Group
    • San Diego, California, United States, 92115-1754
      • West Coast Eye Care
  • Florida
    • Brooksville, Florida, United States, 34613
      • Hernando Eye Institute
    • Miami, Florida, United States, 33176
      • Center for Excellence in Eye Care
  • Illinois
    • Bloomingdale, Illinois, United States, 60108
      • Wohl Eye Center
    • Tinley Park, Illinois, United States, 60477
      • Thomas John Vision Institute
  • Kansas
    • Wichita, Kansas, United States, 67208
      • Grene Vision Group
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care Ltd
  • New Jersey
    • Sewell, New Jersey, United States, 08080
      • David M. Ringel, DO, PA
    • West Paterson, New Jersey, United States, 07424
      • Brar-Parekh Eye Associates
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Park Ophthalmology
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Columbus Ophthalmology Associates
    • Columbus, Ohio, United States, 43210
      • Ohio State University - College of Optometry
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19148
      • Philadelphia Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
  • Texas
    • San Antonio, Texas, United States, 78209
      • Eye Clinics of South Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have best corrected visual acuity in both eyes of at least +0.7 or better
• If female, are non-pregnant or non-lactating
• Have a current diagnosis of blepharitis in one or both eyes

Exclusion Criteria:

• Have lid structural abnormalities
• Have suspected ocular fungal or viral infection
• Have practiced warm compress therapy within 14 days prior to Visit 2
• Unable to withhold the use of contact lenses during the treatment or follow-up periods
• Unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits
• Have had penetrating intraocular surgery within 90 days prior to Visit 2
• Have had ocular surface surgery within the past year prior to Visit 2
• Have a serious medical condition which could confound study assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: Placebo; One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
EXPERIMENTAL: 1	Drug: Azithromycin ophthalmic solution, 1%; One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eyelid margin erythema	Four weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Signs and symptoms of Blepharitis	One week, two weeks, three weeks, four weeks, six weeks, eight weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Chair: Reza Haque, MD,PhD, Medical Monitor, Inspire

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: May 5, 2009
• First Posted (ESTIMATE): May 7, 2009

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

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharitis; Anti-Infective Agents; Anti-Bacterial Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Azithromycin
• Other Study ID Numbers: P08638; 044-102