Status:
COMPLETED
Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
Lead Sponsor:
Azura Ophthalmics
Collaborating Sponsors:
Avania
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)
Detailed Description
AZ202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04391959
Start Date
July 17 2020
End Date
January 6 2021
Last Update
May 16 2022
Active Locations (5)
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1
Fiona Stapleton
Sydney, New South Wales, Australia
2
Scott A Read
Brisbane, Queensland, Australia
3
Susan Thackwray
Maroochydore, Queensland, Australia
4
Jagrut Lallu
Auckland, New Zealand