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

Sponsor
Merck Sharp & Dohme Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT00629980
Collaborator
(none)
60
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2
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

No Intervention: 2

Outcome Measures

Primary Outcome Measures

  1. change in clinical signs and symptoms associated with blepharitis [4 weeks]

Secondary Outcome Measures

  1. standard ocular safety assessments [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Sall Research Medical Center Artesia California United States 90701
2 North Valley Eye Medical Group Mission Hills California United States 91345
3 Center for Excellence in Eye Care Miami Florida United States 33176
4 Kentuckiana Institute for Eye Research Louisville Kentucky United States 40207
5 Tauber Eye Center Kansas City Missouri United States 64111
6 Silverstein Eye Centers Kansas City Missouri United States 64133
7 South Shore Eye Care, LLP Wantagh New York United States 11793
8 Toyos Clinic Jackson Tennessee United States 38301
9 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00629980
Other Study ID Numbers:
  • 041-105
  • P08651
First Posted:
Mar 6, 2008
Last Update Posted:
Sep 26, 2011
Last Verified:
Sep 1, 2011
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2011