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

Sponsor
Merck Sharp & Dohme Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT00629590
Collaborator
(none)
20
Enrollment
1
Location
2
Arms

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 :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-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 for Two Weeks in Subjects With Posterior Blepharitis
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Jul 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 ~12 days
Other Names:
  • AzaSite

    		•
    No Intervention: 2

    Outcome Measures

    Primary Outcome Measures

    1. Change in clinical signs and symptoms associated with blepharitis [2 weeks]

    Secondary Outcome Measures

    1. Standard ocular safety assessments [2 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 posterior 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 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 South Shore Eye Care Wantagh New York United States 11793

    Sponsors and Collaborators

    • Merck Sharp & Dohme Corp.

    Investigators

    • Study Director: Reza Haque, works for Sponsor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00629590
    Other Study ID Numbers:
    • 041-106
    • P08649
    First Posted:
    Mar 6, 2008
    Last Update Posted:
    Sep 26, 2011
    Last Verified:
    Sep 1, 2011
    Additional relevant MeSH terms:
    Blepharitis
    Azithromycin

    Study Results

    No Results Posted as of Sep 26, 2011