Study to Determine the Effect of Azasite on Corneal Surface Irregularity

• Status: Withdrawn
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Philadelphia Eye Associates
• Collaborators: Merck Sharp & Dohme Corp.; Thomas Jefferson University
• Treatments: Azithromycin

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