Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)
NCT ID: NCT05548491
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2022-11-10
2023-10-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AZR-MD-001 1.0%
AZR-MD-001 ointment/semi-solid drug (1.0%)
AZR-MD-001 ointment/semi-solid drug
ointment/semi-solid drug
AZR-MD-001 vehicle
AZR-MD-001 vehicle
AZR-MD-001 ointment/semi-solid drug
ointment/semi-solid drug
Interventions
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AZR-MD-001 ointment/semi-solid drug
ointment/semi-solid drug
Eligibility Criteria
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Inclusion Criteria
* A history of wearing soft contact lenses for at least 6 months.
* Screening CLDEQ-8 score \>12
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Avania
INDUSTRY
Azura Ophthalmics
INDUSTRY
Responsible Party
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Locations
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University of New South Wales, School of Optometry and Vision Science
Sydney, New South Wales, Australia
Ophthalmic Trials Australia
Teneriffe, Queensland, Australia
Countries
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Other Identifiers
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AZ202201
Identifier Type: -
Identifier Source: org_study_id
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