Study to Determine the Effect of Azasite on Corneal Surface Irregularity

Withdrawn before enrolling · Phase 2

Conditions studied: Meibomian Gland Dysfunction

In brief

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

Key facts

Study ID

NCT01797107

Run by

Philadelphia Eye Associates

People needed

0

Starts

2013-03-01

Expected to finish

2014-07-01

Last updated by the study team

2016-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Philadelphia Eye Associates — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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