A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)

Azura Ophthalmics

Status and phase: Active, not recruiting; Phase 3

Conditions: Dry Eye Disease

Treatments: Other: Vehicle; Drug: AZR-MD-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06329791

AZ202401

Details and patient eligibility

About

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.

Full description

This study is 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.

Following a Screening qualification period, all patients diagnosed with abnormal meibomian gland function and associated symptoms of DED, and meeting the inclusion/exclusion criteria, will be randomized centrally, to treatment in a 1:1 ratio.

Study follow-up visits will be conducted on Day 14, Month 1.5, Month 3, Month 4.5, Month 6, Month 9, and Month 12. Patients will exit the study approximately 13 months after the Baseline visit. Any ongoing treatment-emergent adverse events (TEAEs) will be followed for an additional 30 days following the Month 12 visit.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups, including a placebo group

AZR-MD-001

Experimental group

Description:

AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime.

Treatment:

Drug: AZR-MD-001

Vehicle

Placebo Comparator group

Description:

AZR-MD-001 Vehicle to be administered twice weekly at bedtime.

Treatment:

Other: Vehicle