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

Azura Ophthalmics67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Contact Lens Discomfort

Interventions

AZR-MD-001 ointment/semi-solid drugDRUG

ointment/semi-solid drug

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of New South Wales, School of Optometry and Vision Science

Sydney, New South Wales, Australia

Ophthalmic Trials Australia

Teneriffe, Queensland, Australia

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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).

Time frame: 3 months

Data from ClinicalTrials.gov

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