Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

• Status: Completed
• Trial end date: 2021-01-06
• Target enrollment: 0
• Participant gender: All

Summary

Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azura Ophthalmics
• Collaborator: The University of New South Wales

Criteria

Inclusion Criteria:

• Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit

• Reported dry eye signs and symptoms within the past 3 months:

Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT < 10 seconds in both eyes

Exclusion Criteria:

• Uncontrolled ocular disease (except for MGD) or uncontrolled systemic disease

• Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of ≥24 mm Hg determined by Goldman applanation tonometry or has planned insertion/removal of glaucoma filtration shunts/devices during the study

• Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity

• Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation

• Contact lens use anticipated during the study