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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00894530
First received: May 5, 2009
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Blepharitis
Drug: Azithromycin ophthalmic solution, 1%
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Eyelid margin erythema [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Signs and symptoms of Blepharitis [ Time Frame: One week, two weeks, three weeks, four weeks, six weeks, eight weeks ] [ Designated as safety issue: No ]

Enrollment: 314
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894530

  Hide Study Locations
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
Artesia, California, United States, 90701
Sall Research Medical Center, Inc.
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
Columbus Ophthalmology Associates
Columbus, Ohio, United States, 43213
Ohio State University - College of Optometry
Columbus, Ohio, United States, 43210
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.
Investigators
Study Chair: Reza Haque, MD,PhD Medical Monitor, Inspire
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00894530     History of Changes
Other Study ID Numbers: P08638, 044-102
Study First Received: May 5, 2009
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Azithromycin
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014