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

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    136
  • sponsor
    Azura Ophthalmics
Updated on 24 October 2021
obstruction
dry eye syndrome
corrected visual acuity
eye disease
meibomian gland dysfunction
evaporative dry eye syndrome
meibomian gland obstruction

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)

Description

AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Details
Condition Dry eye syndrome, Keratoconjunctivitis Sicca, Meibomian Gland Dysfunction, Dry Eyes, eye dryness, dry eye
Treatment AZR-MD-001 Low Dose, AZR-MD-001 Mid Dose, AZR-MD-001 High Dose, AZR-MD-001 Vehicle
Clinical Study IdentifierNCT03652051
SponsorAzura Ophthalmics
Last Modified on24 October 2021

Eligibility

Yes No Not Sure

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
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