- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01269658
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
October 29, 2013 updated by: Merck Sharp & Dohme LLC
A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis
The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
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
14 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a current diagnosis of blepharitis
- Have a best corrected visual acuity (BCVA), using corrective lenses if
necessary, in both eyes of at least +0.7
- If female, are non-pregnant or non-lactating
Exclusion Criteria:
- Have a concurrent acute hordeolum (stye) or chalazion
- Have inflammation of the ocular surface
- Have used artificial tears within 48 hours prior to Visit 1 or anticipate
using during the study
- Have had ocular surgery in the past 90 days or will require it during the
study
- Unable to withhold the use of contact lenses during the study
- Have a known hypersensitivity to azithromycin, erythromycin, any other
macrolide antibiotic, or any of the other ingredients in the study
medication
- Have been diagnosed with ongoing glaucoma
- Unable to withhold the use of ocular cosmetic products within 48 hours
prior to Visit 1 and throughout the study
- Have a serious medical condition which could confound study assessments
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle
|
1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
|
Experimental: Azithromycin ophthalmic solution, 1%
|
1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resolution of clinical signs of blepharitis
Time Frame: Day 28
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first clinical resolution
Time Frame: Days 7, 14, 21, 28, 42, 56, 70, and 84
|
Days 7, 14, 21, 28, 42, 56, 70, and 84
|
Mean and change from baseline for clinical signs of blepharitis
Time Frame: Days 7, 14, 21, 28, 42, 56, 70, and 84
|
Days 7, 14, 21, 28, 42, 56, 70, and 84
|
Mean and change from end of dosing for clinical signs of blepharitis
Time Frame: Days 42, 56, 70, and 84
|
Days 42, 56, 70, and 84
|
Response to the Blepharitis Symptoms Questionnaire (BSQ)
Time Frame: Days 1, 7, 14, 21, 28, 42, 56, 70, and 84
|
Days 1, 7, 14, 21, 28, 42, 56, 70, and 84
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Charles Johnson, MBChB, Chief Medical Officer
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
December 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
December 21, 2010
First Submitted That Met QC Criteria
January 3, 2011
First Posted (Estimate)
January 4, 2011
Study Record Updates
Last Update Posted (Estimate)
November 21, 2013
Last Update Submitted That Met QC Criteria
October 29, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P08636
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.
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