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An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)

A Single-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 as Adjunctive Therapy to Conventional Therapeutic Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)

NCT03972501•Azura Ophthalmics

View on ClinicalTrials.gov

Summary

SOVS2019-070 is a single-center study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).

Detailed Description

SOVS2019-070 is a single-center, single-masked (the individual(s) performing efficacy measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized, parallel group study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•MGD Patients:
•* Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
•* Reported dry eye signs and symptoms within the past 3 months
•* TBUT \< 10 seconds in both eyes
•CLD Patients:
•* Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit
•* A history of wearing soft contact lenses for at least 6 months
•* Wearing of the soft contact lenses for at least 3 weeks before the baseline visit and wore or attempted to wear lenses at least 4 times a week before the baseline visit.
•* Symptomatic as defined by an answer of "No" at baseline to the question, "Are you able to comfortably wear your lenses as long as you want?"
•* Self-reported history of contact lens dryness/intolerance in the 6 months preceding the baseline visit.
+2 more criteria

Exclusion Criteria

•Uncontrolled ocular disease (except for MGD or CLD) or uncontrolled systemic disease
•Patient has glaucoma or ocular hypertension
•Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity
•BCVA worse than 20/40 in either eye at the baseline visit

Locations (1)

School of Optometry and Vision Science, University of New South Wales

Sydney, New South Wales, Australia

Key Dates

Start Date

October 4, 2019

Primary Completion Date

December 11, 2020

Completion Date

December 11, 2020

Last Updated

January 25, 2023

Enrollment

ACTUAL participants

Conditions

Meibomian Gland Dysfunction (MGD)Contact Lens Discomfort (CLD)

Interventions

AZR-MD-001 Vehicle

DRUG

AZR-MD-001 Active Dose

DRUG

Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction

NCT07224529

Meibomian Gland Dysfunction (MGD)

View study

COMPLETEDNA

Treatment of Meibomian Gland Dysfunction

NCT01683318

Meibomian Gland Dysfunction (MGD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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