Back to resultsSafety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis
Primary Purpose
Blepharitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AzaSite®
Sponsored by
About this trial
This is an interventional treatment trial for Blepharitis
Eligibility Criteria
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
Sites / Locations
- South Shore Eye Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Change in clinical signs and symptoms associated with blepharitis
Secondary Outcome Measures
Standard ocular safety assessments
Full Information
NCT ID
NCT00629590
First Posted
February 21, 2008
Last Updated
September 20, 2011
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00629590
Brief Title
Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis
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 Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
AzaSite®
Other Intervention Name(s)
AzaSite
Intervention Description
ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~12 days
Primary Outcome Measure Information:
Title
Change in clinical signs and symptoms associated with blepharitis
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Standard ocular safety assessments
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Haque
Organizational Affiliation
works for Sponsor
Official's Role
Study Director
Facility Information:
Facility Name
South Shore Eye Care
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis
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