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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00894530
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : November 21, 2013
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blepharitis Drug: Azithromycin ophthalmic solution, 1% Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. Eyelid margin erythema [ Time Frame: Four weeks ]

Secondary Outcome Measures :
  1. Signs and symptoms of Blepharitis [ Time Frame: One week, two weeks, three weeks, four weeks, six weeks, eight weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00894530

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00894530     History of Changes
Other Study ID Numbers: P08638
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Eyelid Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Bacterial Agents
Anti-Infective Agents