Overview

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