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

Dry Eye Disease Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06329791
• Other study ID #: AZ202401
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: Azura Ophthalmics
• Contact: Charles Bosworth, PhD
• Phone: 17145598435
• Email: charles.bosworth[@]azuraophthalmics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• AZR-MD-001
AZR-MD-001 sterile ophthalmic ointment 0.5%

Other:
• Vehicle
AZR-MD-001 Vehicle

Locations

Country	Name	City	State
United States	NC Eye Associates	Apex	North Carolina
United States	Arizona Eye Center	Chandler	Arizona
United States	Pankratz Eye Institute	Columbus	Indiana
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Oculus Research, Inc.	Garner	North Carolina
United States	Global Research Management, Inc	Glendale	California
United States	Advancing Vision Research (AVR) - Goodlettsville	Goodlettsville	Tennessee
United States	The Eye Care Institute/Butchertown Clinical Trials	Louisville	Kentucky
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Total Eye Care	Memphis	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	CORE	Shelby	North Carolina
United States	Advancing Vision Research (AVR) - Smyrna	Smyrna	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Azura Ophthalmics	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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