- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629941
Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis
September 20, 2011 updated by: Merck Sharp & Dohme LLC
A Multi-Center, Open-Label Study Evaluating the Cytokine and Eyelid Margin Bacterial Load Levels of Subjects Diagnosed With Chronic Blepharitis Following Dosing With AzaSite® (Azithromycin Ophthalmic Solution) 1%
The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs & symptoms of blepharitis and tear cytokine and eyelid bacterial load levels
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maine
-
Lewiston, Maine, United States, 04240
- Central Maine Eye Care
-
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Massachusetts
-
Andover, Massachusetts, United States, 01810
- Ophthalmic Research Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in clinical signs and symptoms associated with blepharitis
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Standard ocular safety assessments
Time Frame: 4 weeks
|
4 weeks
|
Change in tear cytokine and eyelid bacterial load levels
Time Frame: 4 Weeks
|
4 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Reza Haque, MD, Sponsor GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
February 27, 2008
First Submitted That Met QC Criteria
March 5, 2008
First Posted (Estimate)
March 6, 2008
Study Record Updates
Last Update Posted (Estimate)
September 26, 2011
Last Update Submitted That Met QC Criteria
September 20, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 041-104
- P08652
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Blepharitis
-
Laboratoires TheaCompleted
-
NTC srlCompletedBilateral Blepharitis (Disorder)Italy
-
Tarsus Pharmaceuticals, Inc.RecruitingDemodex BlepharitisUnited States
-
Istanbul University - Cerrahpasa (IUC)Koç UniversityCompleted
-
Shaare Zedek Medical CenterRecruiting
-
University of California, Los AngelesTerminatedAnterior BlepharitisUnited States
-
Istanbul University - Cerrahpasa (IUC)Koç UniversityCompleted
-
Sun Pharmaceutical Industries LimitedCompletedActive, Symptomatic BlepharitisUnited States
-
Tehran University of Medical SciencesCompletedPosterior BlepharitisIran, Islamic Republic of
-
Universidad Nacional de ColombiaCompletedChronic BlepharitisColombia
Clinical Trials on AzaSite®
-
Merck Sharp & Dohme LLCCompletedBlepharitisUnited States
-
Merck Sharp & Dohme LLCCompletedBlepharitisUnited States
-
Merck Sharp & Dohme LLCCompletedBlepharitisUnited States
-
Merck Sharp & Dohme LLCCompletedBacterial ConjunctivitisUnited States
-
Philadelphia Eye AssociatesMerck Sharp & Dohme LLC; Thomas Jefferson UniversityWithdrawnMeibomian Gland DysfunctionUnited States
-
Sun Pharmaceutical Industries LimitedWithdrawn
-
Sun Pharmaceutical Industries LimitedCompleted
-
University of LouisvilleCompleted
-
Merck Sharp & Dohme LLCCompletedBacterial ConjunctivitisUnited States
-
Beijing Tongren HospitalZhuhai Essex Bio-Pharmaceutical Company Limited; Panacea TechnologiesUnknownBacterial ConjunctivitisChina