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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZR-MD-001 1.0% | Experimental | AZR-MD-001 ointment/semi-solid drug (1.0%) |
|
| AZR-MD-001 vehicle | Placebo Comparator | AZR-MD-001 vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZR-MD-001 ointment/semi-solid drug | Drug | ointment/semi-solid drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New South Wales, School of Optometry and Vision Science | Sydney | New South Wales | Australia | |||
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 28, 2025 | Feb 18, 2025 | 4 | ||
| Feb 18, 2025 |
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single-masked
| Ophthalmic Trials Australia |
| Teneriffe |
| Queensland |
| Australia |
| Mar 7, 2025 |
| 5 |
| Jul 17, 2025 | Aug 4, 2025 | 6 |
| Aug 15, 2025 | Aug 21, 2025 | 7 |
| Oct 2, 2025 | Oct 29, 2025 | 8 |
| Nov 6, 2025 | Nov 19, 2025 | 9 |