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

NCT05548491 | Completed Phase 2 FDA Drug

• 1 other identifier: AZ202201
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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.

Conditions

Contact Lens Discomfort

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

AZR-MD-001 1.0%

EXPERIMENTAL

AZR-MD-001 ointment/semi-solid drug (1.0%)

Drug: AZR-MD-001 ointment/semi-solid drug

AZR-MD-001 vehicle

PLACEBO COMPARATOR

AZR-MD-001 vehicle

Drug: AZR-MD-001 ointment/semi-solid drug

Interventions

AZR-MD-001 ointment/semi-solid drug DRUG

ointment/semi-solid drug

AZR-MD-001 1.0%; AZR-MD-001 vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azura Ophthalmics: lead
• Avania: collaborator

Study Sites (2)

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

Sydney, New South Wales, Australia

Location

Ophthalmic Trials Australia

Teneriffe, Queensland, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 21, 2022
• Study Start: November 10, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)