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Ointment

A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

Phase 2
Waitlist Available
Led By Stephanie L Watson
Research Sponsored by Azura Ophthalmics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up value at month 3 minus value at baseline

Summary

This trial is testing a new ointment called AZR-MD-001 in patients with Meibomian Gland Dysfunction and evaporative Dry Eye Disease. The goal is to see if the ointment can help improve the function of eye glands that produce oils, which are essential for keeping the eyes moist. This could provide a new treatment option for people who suffer from dry eyes.

Eligible Conditions
  • Meibomian Gland Dysfunction
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~value at month 3 minus value at baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and value at month 3 minus value at baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Meibomian Glands Yielding Liquid Secretion (MGYLS)
Ocular Surface Disease Index (OSDI) Total Score
Secondary study objectives
Meibum Gland Secretion Score (MGS)

Side effects data

From 2022 Phase 2 trial • 321 Patients • NCT03652051
13%
Administration site reaction
13%
Foreign body sensation
6%
Application site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stage 1: AZR-MD-001 Vehicle
Stage 2: AZR-MD-001 Mid Dose
Stage 2: AZR-MD-001 High Dose
Stage 2: AZR-MD-001 Vehicle
Stage 1: AZR-MD-001 Low Dose
Stage 1: AZR-MD-001 Mid Dose
Stage 1: AZR-MD-001 High Dose

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: AZR-MD-001 Mid DoseExperimental Treatment1 Intervention
AZR-MD-001 Mid Dose will be dosed up to once daily.
Group II: AZR-MD-001 Low DoseExperimental Treatment1 Intervention
AZR-MD-001 Low Dose will be dosed up to once daily.
Group III: AZR-MD-001 High DoseExperimental Treatment1 Intervention
AZR-MD-001 High Dose will be dosed up to once daily.
Group IV: AZR-MD-001 VehiclePlacebo Group1 Intervention
AZR-MD-001 Vehicle will be dosed up to once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZR-MD-001 Low Dose
2018
Completed Phase 2
~330
AZR-MD-001 Mid Dose
2018
Completed Phase 2
~330
AZR-MD-001 High Dose
2018
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

Cliantha ResearchUNKNOWN
1 Previous Clinical Trials
40 Total Patients Enrolled
Azura OphthalmicsLead Sponsor
5 Previous Clinical Trials
656 Total Patients Enrolled
3 Trials studying Meibomian Gland Dysfunction
89 Patients Enrolled for Meibomian Gland Dysfunction
Syneos HealthOTHER
176 Previous Clinical Trials
68,334 Total Patients Enrolled
Stephanie L WatsonPrincipal InvestigatorSave Sight Institute
~44 spots leftby Dec 2025
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