A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

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

Details

• Lead Sponsor: Azura Ophthalmics
• Collaborators: Cliantha Research; Syneos Health

Criteria

Inclusion Criteria:

• Male or female, 18 years of age or older

• Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye

• Evidence of meibomian gland obstruction

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

Exclusion Criteria:

• Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease

• Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening ≥24 mm Hg 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 or corneal integrity

• BCVA worse than 20/40 in either eye

• Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye