Study to Determine the Effect of Azasite on Corneal Surface Irregularity

NCT ID: NCT01797107

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-07-31

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.

Conditions

Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment eye

Azasite (azithromycin ophthalmic 1%) twice a day for 2 days followed by nightly for 4 weeks

Group Type: EXPERIMENTAL

Azasite

Intervention Type: DRUG

Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks.

Durasite

Vehicle of Azasite used as placebo

Group Type: PLACEBO_COMPARATOR

Azasite

Intervention Type: DRUG

Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks.

Interventions

Azasite

Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks.

Intervention Type: DRUG

Other Intervention Names

Azithromycin ophthalmic 1%

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

Philadelphia Eye Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brad H Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Philadelphia Eye Associates

Locations

Philadelphia Eye Associates

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

40958

Identifier Type: -

Identifier Source: org_study_id