Clinical trial NCT06329791: A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Azura Ophthalmics
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2024-03-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in Meibomian Glands Yielding Liquid Secretion
timeFrame: Month 3
measure: Change from baseline in Total Ocular Surface Disease Index Score
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Glendale
country: United States
facility: Global Research Management, Inc
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Torrance
country: United States
facility: NVISION Clinical Research
state: California
city: Northbrook
country: United States
facility: Wyse Eyecare
state: Illinois
city: Columbus
country: United States
facility: Pankratz Eye Institute
state: Indiana
city: Louisville
country: United States
facility: The Eye Care Institute/Butchertown Clinical Trials
state: Kentucky
city: St. Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Apex
country: United States
facility: NC Eye Associates
state: North Carolina
city: Garner
country: United States
facility: Oculus Research, Inc.
state: North Carolina
city: Shelby
country: United States
facility: CORE
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott &amp; Christie and Associates, PC
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Advancing Vision Research (AVR) - Goodlettsville
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research (AVR) - Smyrna
state: Tennessee
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
affiliation: Azura Ophthalmics
name: Charles Bosworth, PhD
role: STUDY_DIRECTOR
References: