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

Phase 2

Completed

• Conditions: Contact Lens Discomfort
• Interventions: Drug: AZR-MD-001 ointment/semi-solid drug

• Registration Number: NCT05548491
• Lead Sponsor: Azura Ophthalmics

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-09-17
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-21
• Study Start: 2022-11-10
• Status Verified: 2023-10
• Primary Completion: 2023-10-13
• Study Completion: 2023-10-13
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZR-MD-001 1.0%	AZR-MD-001 ointment/semi-solid drug	AZR-MD-001 ointment/semi-solid drug (1.0%)
AZR-MD-001 vehicle	AZR-MD-001 ointment/semi-solid drug	AZR-MD-001 vehicle

Primary Outcome Measures

Name	Time	Method
Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS)	3 months	Change from baseline to month 3 in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS)
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score	3 months	Change from baseline to month 3 in CLDEQ-8 total score. Scores can range from 0 (normal) to 37 (Impacted Contact Use).
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) fluctuating vision	3 months	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)

Trial Locations

Locations (2)

Ophthalmic Trials Australia; 🇦🇺 Teneriffe, Queensland, Australia

University of New South Wales, School of Optometry and Vision Science; 🇦🇺 Sydney, New South Wales, Australia