Trial | NCT03652051  Report issue

Title

A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)
A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) and Evaporative Dry Eye Disease (DED)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    245
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)
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)
Study Started
Sep 10
2018
Primary Completion
Sep 14
2022
Study Completion
Oct 19
2022
Last Update
Nov 25
2022

Drug AZR-MD-001 Low Dose

AZR-MD-001 is an ophthalmic ointment

Drug AZR-MD-001 Mid Dose

AZR-MD-001 is an ophthalmic ointment

Drug AZR-MD-001 High Dose

AZR-MD-001 is an ophthalmic ointment

Drug AZR-MD-001 Vehicle

AZR-MD-001 is a vehicle ophthalmic ointment

AZR-MD-001 Low Dose Experimental

AZR-MD-001 Low Dose will be dosed up to once daily.

AZR-MD-001 Mid Dose Experimental

AZR-MD-001 Mid Dose will be dosed up to once daily.

AZR-MD-001 High Dose Experimental

AZR-MD-001 High Dose will be dosed up to once daily.

AZR-MD-001 Vehicle Sham Comparator

AZR-MD-001 Vehicle will be dosed up to once daily.

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
No Results Posted