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

NCT06329791 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-09-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AZR-MD-001

AZR-MD-001 sterile ophthalmic ointment 0.5%

OTHER

Vehicle

AZR-MD-001 Vehicle

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Azura Ophthalmics

    lead INDUSTRY

Principal Investigators

  • Charles Bosworth, PhD · Azura Ophthalmics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2024-12-31
Completion
2025-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06329791 on ClinicalTrials.gov