Clinical trial NCT01797107: Study to Determine the Effect of Azasite on Corneal Surface Irregularity
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Azasite on Corneal Surface Irregularity in Subjects With Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Meibomian Gland Dysfunction
Keywords: Meibomian gland dysfunction
Lead sponsor: Philadelphia Eye Associates
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Thomas Jefferson University
First posted: 2013-02-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 MGD-related evaporative dry eye. All patients will be evaluated at screening, baseline, two weeks, four weeks, and six weeks.

The primary outcome measure will be improvement, as compared to baseline, in corneal irregularity as measured by a topographically-derived value, the Corneal Irregularity Measurement (CIM). Secondary outcome measures will be a global symptom score, tear film break up time, meibomian gland secretion characteristics, best-corrected distance visual acuity, corneal staining, axial topography based astigmatism patterns, and IOL Master keratometry.

We will enroll 60 eyes of 30 patients, and each patient will be randomly assigned to receive Azasite in one eye and vehicle (Durasite®) in the fellow eye.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Corneal Irregularity Measurement
timeFrame: 4 weeks
Secondary outcomes:
measure: Global symptoms score
timeFrame: 2,4 and 6 weeks
measure: Meibomian gland secretion characteristics
timeFrame: 2, 4 and 6 weeks
measure: Best corrected distance visual acuity
timeFrame: 2, 4 and 6 weeks
measure: Corneal staining
timeFrame: 2, 4 and 6 weeks
measure: Axial topography based astigmatism pattern
timeFrame: 2, 4 and 6 weeks
measure: Intraocular Lens(IOL) Master Keratometry
timeFrame: 2, 4 and 6 weeks
measure: Change in Corneal Irregularity Measurement
timeFrame: 2 weeks, 6 weeks
Other outcomes:
measure: Tear film break-up time
timeFrame: 2, 4 and 6 weeks
Locations:
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
Study officials:
affiliation: Philadelphia Eye Associates
name: Brad H Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References: