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

Study Overview
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Brief Summary
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AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Detailed Description
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AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Official Title
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A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) and Evaporative Dry Eye Disease (DED)

Conditions
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Meibomian Gland Dysfunction, Dry Eye

Intervention / Treatment
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* Drug: AZR-MD-001 Low Dose
* Drug: AZR-MD-001 Mid Dose
* Drug: AZR-MD-001 High Dose
* Drug: AZR-MD-001 Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years of age or older Best-corrected visual acuity (BCVA) of 20/40 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye Evidence of meibomian gland obstruction Reported dry eye signs and symptoms within the past 3 months Exclusion Criteria: Uncontrolled ocular disease (except for MGD and dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease Glaucoma, ocular hypertension, or intraocular pressure (IOP) in either eye at screening ≥24 mm Hg or has planned insertion/removal of glaucoma filtration shunts/devices during the study Corneal abnormality or disorder that impacts normal spreading of the tear film or corneal integrity BCVA worse than 20/40 in either eye Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZR-MD-001 Low Dose<br>AZR-MD-001 Low Dose will be dosed up to once daily. | Drug: AZR-MD-001 Low Dose<br>* AZR-MD-001 is an ophthalmic ointment<br>|
| Experimental: AZR-MD-001 Mid Dose<br>AZR-MD-001 Mid Dose will be dosed up to once daily. | Drug: AZR-MD-001 Mid Dose<br>* AZR-MD-001 is an ophthalmic ointment<br>|
| Experimental: AZR-MD-001 High Dose<br>AZR-MD-001 High Dose will be dosed up to once daily. | Drug: AZR-MD-001 High Dose<br>* AZR-MD-001 is an ophthalmic ointment<br>|
| Sham Comparator: AZR-MD-001 Vehicle<br>AZR-MD-001 Vehicle will be dosed up to once daily. | Drug: AZR-MD-001 Vehicle<br>* AZR-MD-001 is a vehicle ophthalmic ointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibum Gland Secretion Score (MGS) | Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal) | Month 3 | 
| Meibomian Glands Yielding Liquid Secretion (MGYLS) | Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal) | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibum Gland Secretion Score (MGS) | Change from Baseline in MGS. The MGS can range from 0 (highly abnormal) to 45 (Normal) | Day 14, Month 1, Month 1.5 | 
| Meibomian Glands Yielding Liquid Secretion (MGYLS) | Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal) | Day 14, Month 1, Month 1.5 |