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)

SOVS2019-070

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).

2019-10-04

2020-12-11

2020-12-11

Completed

Early phase I

26

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. * Baseline CLDEQ-8 score \>12 * Contact lens may be use during the study as long as they are removed 15 minutes before dosing and not reinserted until at least 15 minutes after dosing. 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

2023-01-25