Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)

Study Overview
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Brief Summary
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AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

Detailed Description
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AZ202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)

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

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: AZR-MD-001 Active
* 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZR-MD-001 Vehicle<br>AZR-MD-001 Vehicle will be dosed up to twice weekly. | Drug: AZR-MD-001 Vehicle<br>* AZR-MD-001 is a vehicle ophthalmic ointment<br>* Other names: AZR-MD-001 Vehicle is an ophthalmic ointment;|
| Experimental: AZR-MD-001 Active<br>AZR-MD-001 Active will be dosed up to twice weekly. | Drug: AZR-MD-001 Active<br>* AZR-MD-001 is an active ophthalmic ointment<br>* Other names: AZR-MD-001 is an ophthalmic ointment;|

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). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands will be evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions, as shown below. For each of the 15 glands, expressed secretion characteristics will be graded on a 0-3 scale. For more detail see: Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (MGD). Cornea. 2012; 31(4): 396-404. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total OSDI | Change from Baseline in Total Ocular Surface Disease Index (OSDI). The Total OSDI can range from 0 (normal) to 100 (abnormal). The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The patient was asked to rate each symptom using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. Seven questions related to visual functioning allow a response of N/A (not applicable). The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: ([sum of scores for all questions answereda] X 100)/([total number of questions answered] X 4). Questions answered with N/A were excluded in the calculation of total OSDI. | Day 14 to Month 3 |