A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)
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
2 other identifiers
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedDecember 16, 2013
December 1, 2013
9 months
October 12, 2010
December 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline of investigator-rated scores for eyelid margin erythema
Week 4
Secondary Outcomes (2)
Change from baseline of investigator-rated scores of blepharoconjunctivitis signs
Weeks 2, 4, 6, 8
Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms
Weeks 2, 4, 6, 8
Study Arms (1)
Azithromycin ophthalmic solution, 1%
EXPERIMENTALInterventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine
Houston, Texas, 77030, United States
Study Officials
- STUDY CHAIR
Reza Haque, MD, PhD
Medical Monitor
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2010
First Posted
October 13, 2010
Study Start
November 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
December 16, 2013
Record last verified: 2013-12