Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)

Study Overview
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Brief Summary
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A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.

Detailed Description
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A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2. For Stage 1 of the study, up to 12 participants who experience symptoms of CLD and experience concomitant meibomian gland dysfunction will complete a Screening visit followed by a hybrid concept elicitation and cognitive debriefing interview which can occur at the end of the Screening visit or up to 14 days later. Stage 2 is a multi-center, single-masked, vehicle-controlled, randomized, parallel group study. Participants with CLD will be randomly assigned in a 1:1 ratio to receive either active AZR-MD-001 ointment/semi-solid drug (1.0%) or AZR-MD-001 vehicle for 3 months.

Official Title
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A Two Stage, Multi-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 and to Determine Common Symptoms in Contact Lens Discomfort (CLD)

Conditions
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Contact Lens Discomfort

Intervention / Treatment
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* Drug: AZR-MD-001 ointment/semi-solid drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. A history of wearing soft contact lenses for at least 6 months. Screening CLDEQ-8 score >12 Exclusion Criteria: Active ocular infection (bacterial, viral, or fungal). Participant is unlikely to follow study instructions or to complete all required study visit(s) or has a condition or situation that in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study. Participant is an employee at the investigational site or is related to any member of the study staff. Participation in another clinical trial involving a therapeutic drug or device within the past 30 days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZR-MD-001 1.0%<br>AZR-MD-001 ointment/semi-solid drug (1.0%) | Drug: AZR-MD-001 ointment/semi-solid drug<br>* ointment/semi-solid drug<br>|
| Placebo Comparator: AZR-MD-001 vehicle<br>AZR-MD-001 vehicle | Drug: AZR-MD-001 ointment/semi-solid drug<br>* ointment/semi-solid drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS) | Change from baseline to month 3 in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS) | 3 months | 
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) fluctuating vision | Change from baseline to month 3 in CLDEQ-8 fluctuating vision items. Scores can range from 0 (normal) to 9 (impacted vision). (summed responses to questions 3a and 3b only) | 3 months | 
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score | Change from baseline to month 3 in CLDEQ-8 total score. Scores can range from 0 (normal) to 37 (Impacted Contact Use). | 3 months |