Study to Determine the Effect of Azasite on Corneal Surface Irregularity

Philadelphia Eye Associates

Status and phase

Withdrawn

Phase 2

Conditions

Meibomian Gland Dysfunction

Treatments

Drug: Azasite

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01797107

40958

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of Azasite on patients with corneal surface irregularity (meibomian gland dysfunction).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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