Clinical trial

A Phase 3, Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Efficacy, Safety, and Tolerability of AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Associated Symptoms of Dry Eye Disease (DED)

Name

AZ202401

Description

This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.

Trial arms

Trial start

2024-05-01

Estimated PCD

2024-12-01

Trial end

2025-11-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

AZR-MD-001

AZR-MD-001 sterile ophthalmic ointment 0.5%

Arms:

AZR-MD-001

Other names:

AZR-MD-001 ophthalmic ointment 0.5%

Vehicle

AZR-MD-001 Vehicle

Arms:

Vehicle

Other names:

AZR-MD-001 Vehicle

Size

500

Primary endpoint

Change from baseline in Meibomian Glands Yielding Liquid Secretion

Month 3

Change from baseline in Total Ocular Surface Disease Index Score

Month 3

Eligibility criteria

Inclusion Criteria: * Male or female, 18 years of age or older at Screening. * Evidence of active Evaporative DED at Screening and Baseline. * Evidence of meibomian gland obstruction in both eyes at Screening and Baseline. Exclusion Criteria: * Ocular disease (except for Meibomian Gland Dysfunction (MGD) and DED/keratoconjunctivitis sicca) or systemic disease determined to be uncontrolled by the investigator. * Patient has glaucoma, ocular hypertension, or an intraocular pressure (IOP) of ≥24 mm Hg in either eye at Screening. * Recent (within the past 3 months of Screening) ocular surgery, trauma, herpes, or recurrent inflammation. * Unwilling to abstain from the use of systemic or topical treatments for MGD or dry eye for the study duration.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

Updated at

2024-04-24

1 organization

1 product

1 indication

Organization

Azura Ophthalmics

Product

AZR-MD-001

Indication

Dry Eye Syndrome