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| Name | Class |
|---|---|
| The University of New South Wales | OTHER |
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Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.
Randomized study with 6 visits. For all dose groups a screening visit will be followed by a baseline visit 14 days later (qualification period). At the end of the qualification period patients who still exhibit signs of Meibomian Gland Dysfunction (MGD) at the baseline visit will be enrolled into a 3-month treatment period. At the baseline (Day 0) visit, patients will be randomly assigned to receive either AZR-MD-001 ointment/semi-solid drug or AZR-MD-001 vehicle twice-weekly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZR-MD-001 Active | Experimental | AZR-MD-001 ointment/semi-solid drug (1.0%) |
|
| AZR-MD-001 Active + Conventional Treatment | Experimental | AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte® |
|
| AZR-MD-001 vehicle | Experimental | AZR-MD-001 vehicle control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZR-MD-001 ointment/semi-solid drug | Drug | AZR-MD-001 (1.0%) and suitable excipient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS) | The MGS can range from 0 (highly abnormal) to 45 (Normal). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands were evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions. For each of the 15 glands, expressed secretion characteristics were graded on a 0-3 scale using the published methods from Lane and Colleagues (2012) Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (MGD). Cornea. 2012; 31(4): 396-404. | Month 3 |
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Inclusion Criteria:
Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT < 10 seconds in both eyes
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fiona Stapleton | Sydney | New South Wales | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZR-MD-001 Active | AZR-MD-001 ointment/semi-solid drug (1.0%) AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient |
| FG001 | AZR-MD-001 Vehicle | AZR-MD-001 vehicle control AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZR-MD-001 Active | AZR-MD-001 ointment/semi-solid drug (1.0%) AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient |
| BG001 | AZR-MD-001 Vehicle | AZR-MD-001 vehicle control AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Efficacy for MGD: Change From Baseline to Month 3 in Meibomian Gland Secretion Score (MGS) | The MGS can range from 0 (highly abnormal) to 45 (Normal). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands were evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions. For each of the 15 glands, expressed secretion characteristics were graded on a 0-3 scale using the published methods from Lane and Colleagues (2012) Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (MGD). Cornea. 2012; 31(4): 396-404. | Modified Intent to Treat | Posted | Mean | Standard Deviation | Units on the MGS Scale | Month 3 |
|
3 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZR-MD-001 Active | AZR-MD-001 ointment/semi-solid drug (1.0%) AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Bosworth | Azura Ophthalmics | 17145598435 | charles.bosworth@azuraophthalmics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2020 | Feb 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
AZR-MD-001 ointment/semi-solid drug (1.0%)
AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient
| OG001 | AZR-MD-001 Vehicle | AZR-MD-001 vehicle control AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 14 |
| 19 |
| EG001 | AZR-MD-001 Vehicle | AZR-MD-001 vehicle control AZR-MD-001 ointment/semi-solid drug: AZR-MD-001 (1.0%) and suitable excipient | 0 | 10 | 0 | 10 | 2 | 10 |
| Eye Irritation | Eye disorders | Systematic Assessment |
|
| Ocular Discomfort | Eye disorders | Systematic Assessment |
|
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