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| Name | Class |
|---|---|
| The University of New South Wales | OTHER |
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SOVS2019-070 is a single-center study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).
SOVS2019-070 is a single-center, single-masked (the individual(s) performing efficacy measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized, parallel group study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZR-MD-001 Vehicle | Placebo Comparator | AZR-MD-001 Vehicle will be dosed up to once daily. |
|
| AZR-MD-001 Active Dose | Experimental | AZR-MD-001 Active Dose will be dosed up to once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZR-MD-001 Vehicle | Drug | AZR-MD-001 is an ophthalmic ointment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum 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 methods published by 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 4 |
| Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS). | The MGYLS can range from 0 (highly abnormal) to 15 (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. The number of glands secreting any liquid were counted using the methods published by 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 4 |
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Inclusion Criteria:
MGD Patients:
CLD Patients:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry and Vision Science, University of New South Wales | Sydney | New South Wales | 2052 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZR-MD-001 Vehicle | AZR-MD-001 Vehicle will be dosed up to once daily. AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment |
| FG001 | AZR-MD-001 Active Dose | AZR-MD-001 Active Dose will be dosed up to once daily. AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZR-MD-001 Vehicle | AZR-MD-001 Vehicle will be dosed up to once daily. AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment |
| BG001 | AZR-MD-001 Active Dose | AZR-MD-001 Active Dose will be dosed up to once daily. AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment |
| 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 4 in Meibum 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 methods published by 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 Meibomian Gland Score scale | Month 4 |
|
4 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 Vehicle | AZR-MD-001 Vehicle will be dosed up to once daily. AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Irritation | 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 | Feb 17, 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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| AZR-MD-001 Active Dose |
| Drug |
AZR-MD-001 is an ophthalmic ointment |
|
| 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 Vehicle will be dosed up to once daily.
AZR-MD-001 Vehicle: AZR-MD-001 is an ophthalmic ointment
| OG001 | AZR-MD-001 Active Dose | AZR-MD-001 Active Dose will be dosed up to once daily. AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment |
|
|
| Primary | Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS). | The MGYLS can range from 0 (highly abnormal) to 15 (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. The number of glands secreting any liquid were counted using the methods published by 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 MGYLS scale | Month 4 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | AZR-MD-001 Active Dose | AZR-MD-001 Active Dose will be dosed up to once daily. AZR-MD-001 Active Dose: AZR-MD-001 is an ophthalmic ointment | 0 | 13 | 0 | 13 | 3 | 13 |
| Eye Pain | Eye disorders | Systematic Assessment |
|
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