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

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06329791

Enrollment

500

Registered

2024-03-26

Start date

2024-05-28

Completion date

2025-11-30

Last updated

2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Brief summary

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.

Detailed 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.

Interventions

DRUGAZR-MD-001

AZR-MD-001 sterile ophthalmic ointment 0.5%

OTHERVehicle

AZR-MD-001 Vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in Meibomian Glands Yielding Liquid Secretion	Month 3	Meibomian Glands Yielding Liquid Secretion (MGYLS) measures the number of meibomian glands (0 - 15) secreting liquid
Change from baseline in Total Ocular Surface Disease Index Score	Month 3	The Total Ocular Surface Disease Index Score (OSDI) provides a score from 0 (normal) to 100 (abnormal)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026