Status:
WITHDRAWN
Study to Determine the Effect of Azasite on Corneal Surface Irregularity
Lead Sponsor:
Philadelphia Eye Associates
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Thomas Jefferson University
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of Azasite on patients with corneal surface irregularity (meibomian gland dysfunction).
Detailed Description
This will be a single-center, randomized, vehicle-controlled, double-masked, clinical trial comparing a four week course of Azasite (azithromycin ophthalmic 1%) to vehicle (Durasite®) in patients with...
Eligibility Criteria
Inclusion
- Ability to provide informed consent prior to enrollment in study
- Patient ability to follow study instructions and comply with all study protocols
- Corneal irregularity measurement (CIM) \> 1.7 in both eyes
- Non-atrophic meibomian gland dysfunction (MGD) as defined by abnormal meibomian expression in at least 2 meibomian glands of the eyelids of each eye
- At least two symptoms of at least moderate severity (≥ grade 2, 0 to 3 scale) as defined in the MGD Global Symptom Score (Itching, Foreign-body sensation, Dryness, Burning, Lid swelling)
- Tear film break up time \< 10 seconds
- Schirmer with anesthesia \> 5 mm
- Best corrected distance visual acuity (BCDVA) \> 20/100
Exclusion
- Cicatricial or atrophic meibomian gland dysfunction (MGD)
- Any corneal disease or scar involving the central 6 mm, including epithelial basement membrane dystrophy, Salzmann nodular degeneration, recurrent erosions, keratoconus or ectasia
- Use of azithromycin or doxycycline within 1 month of screening
- Topical ocular antibiotic, anti-histamines, allergy, or steroid medication within 2 weeks of baseline (a 2 week washout after screening will be allowed)
- Topical prostaglandin analogue use within 30 days of study
- The anticipated use of any drops, gels or ointments during the study period outside of the study protocol
- Use of eye make-up during study period
- Active ocular infection or inflammation
- History of herpetic eye disease or neurotrophic keratitis
- Lid pathology (except MGD or blepharitis) that the examiner feels may affect the ocular surface
- Significant conjunctival scars (ex. h/o SJS)
- Pterygium
- Lacrimal punctal occlusion within 2 months of screening
- Ocular surgery within 1 year of screening
- Monocular patients
- Pregnant, breast-feeding, or sexually active females not using contraception
- Uncontrolled systemic disease
- Presence of any disease (medical or ocular) that, in the opinion of the investigator, may interfere with the study's safety or interpretation
- Known allergy to the study medication or its components
- Current enrollment in an investigational drug or device study within 30 days of screening for this study
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01797107
Start Date
March 1 2013
End Date
July 1 2014
Last Update
September 28 2016
Active Locations (1)
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1
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States, 19148