Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00629980
First received: February 27, 2008
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.


Condition Intervention Phase
Blepharitis
Drug: AzaSite®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone in Subjects With Blepharitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • change in clinical signs and symptoms associated with blepharitis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • standard ocular safety assessments [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AzaSite®
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
Other Name: AzaSite®
No Intervention: 2

  Eligibility

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

Inclusion Criteria:

  • diagnosis of moderate to severe chronic blepharitis
  • if female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

  • had ocular surface surgery (LASIK, refractive, etc.) within the past year
  • unwilling to discontinue the use of contact lenses during the study
  • have glaucoma
  • unable or unwilling to withhold the use of lid scrubs during the study
  • have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
  • currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
  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: NCT00629980

Locations
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Kentucky
Kentuckiana Institute for Eye Research
Louisville, Kentucky, United States, 40207
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133
United States, New York
South Shore Eye Care, LLP
Wantagh, New York, United States, 11793
United States, Tennessee
Toyos Clinic
Jackson, Tennessee, United States, 38301
United States, Texas
Corona Research Consultants, Inc.
El Paso, Texas, United States, 79904
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Reza Haque, MD Sponsor GmbH
  More Information

No publications provided

Responsible Party: Mike Schiewe, Inspire Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00629980     History of Changes
Other Study ID Numbers: 041-105, P08651
Study First Received: February 27, 2008
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014