Back to resultsA Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)
Primary Purpose
Posterior Blepharoconjunctivitis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azithromycin ophthalmic solution, 1%
Sponsored by
About this trial
This is an interventional treatment trial for Posterior Blepharoconjunctivitis
Eligibility Criteria
Inclusion Criteria: Have a current diagnosis of posterior blepharoconjunctivitis in both eyes (except for healthy volunteers) Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR If female, are non-pregnant or non-lactating Exclusion Criteria: Have anterior blepharitis Have lid structural abnormalities Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study Unable to withhold the use of contact lenses within 3 days prior to Visit 1 during the study Have been diagnosed with ongoing glaucoma Have a serious medical condition which could confound study assessments
Sites / Locations
- Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Azithromycin ophthalmic solution, 1%
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline of investigator-rated scores for eyelid margin erythema
Secondary Outcome Measures
Change from baseline of investigator-rated scores of blepharoconjunctivitis signs
Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms
Full Information
NCT ID
NCT01220258
First Posted
October 12, 2010
Last Updated
December 13, 2013
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01220258
Brief Title
A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)
Official Title
A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Blepharoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin ophthalmic solution, 1%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Azithromycin ophthalmic solution, 1%
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change from baseline of investigator-rated scores for eyelid margin erythema
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change from baseline of investigator-rated scores of blepharoconjunctivitis signs
Time Frame
Weeks 2, 4, 6, 8
Title
Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms
Time Frame
Weeks 2, 4, 6, 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have a current diagnosis of posterior blepharoconjunctivitis in both eyes
(except for healthy volunteers)
Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR
If female, are non-pregnant or non-lactating
Exclusion Criteria:
Have anterior blepharitis
Have lid structural abnormalities
Have had penetrating intraocular surgery in the past 90 days or require
penetrating intraocular surgery during the study
Unable to withhold the use of contact lenses within 3 days prior to Visit 1
during the study
Have been diagnosed with ongoing glaucoma
Have a serious medical condition which could confound study assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Haque, MD, PhD
Organizational Affiliation
Medical Monitor
Official's Role
Study Chair
Facility Information:
Facility Name
Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)
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