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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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AZ202001 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)
AZ202001 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZR-MD-001 Vehicle | Experimental | AZR-MD-001 Vehicle will be dosed up to twice weekly. |
|
| AZR-MD-001 Active | Experimental | AZR-MD-001 Active will be dosed up to twice weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZR-MD-001 Active | Drug | AZR-MD-001 is an active ophthalmic ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Meibum Gland Secretion Score (MGS) | Change from Baseline in 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 will be evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions, as shown below. For each of the 15 glands, expressed secretion characteristics will be graded on a 0-3 scale. For more detail see: 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total OSDI | Change from Baseline in Total Ocular Surface Disease Index (OSDI). The Total OSDI can range from 0 (normal) to 100 (abnormal). The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The patient was asked to rate each symptom using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. Seven questions related to visual functioning allow a response of "N/A" (not applicable). The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: ([sum of scores for all questions answereda] X 100)/([total number of questions answered] X 4). Questions answered with N/A were excluded in the calculation of total OSDI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Tan-Showyin | School of Optometry and Vision Science, University of New South Wales | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fiona Stapleton | Sydney | New South Wales | Australia | |||
| Scott A Read |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZR-MD-001 Vehicle | AZR-MD-001 Vehicle will be dosed up to twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment |
| FG001 | AZR-MD-001 Active | AZR-MD-001 Active will be dosed up to twice weekly. AZR-MD-001 Active: AZR-MD-001 is an active 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 twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment |
| BG001 | AZR-MD-001 Active | AZR-MD-001 Active will be dosed up to twice weekly. AZR-MD-001 Active: AZR-MD-001 is an active 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 | Meibum Gland Secretion Score (MGS) | Change from Baseline in 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 will be evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions, as shown below. For each of the 15 glands, expressed secretion characteristics will be graded on a 0-3 scale. For more detail see: 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. | Target Population | Posted | Mean | Standard Deviation | score on a 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 Vehicle | AZR-MD-001 Vehicle will be dosed up to twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment | This subject experienced dysuria, severe in severity, which was considered unrelated to either the investigational product or the study procedure. After subject hospitalization for transurethral resection of the prostate, the TEAE resolved. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | 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 | Yes | No | No | Study Protocol | Mar 12, 2020 | Dec 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2021 | Mar 1, 2022 | SAP_001.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 Vehicle | Drug | AZR-MD-001 is a vehicle ophthalmic ointment |
|
|
| Day 14 to Month 3 |
| Brisbane |
| Queensland |
| Australia |
| Susan Thackwray | Maroochydore | Queensland | Australia |
| Jagrut Lallu | Auckland | New Zealand |
| Jennifer P Craig | Auckland | New Zealand |
| 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 |
|
| OG001 | AZR-MD-001 Active | AZR-MD-001 Active will be dosed up to twice weekly. AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment |
|
|
| Secondary | Total OSDI | Change from Baseline in Total Ocular Surface Disease Index (OSDI). The Total OSDI can range from 0 (normal) to 100 (abnormal). The OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning. The patient was asked to rate each symptom using a 5-point scale (0 to 4), where 0 = none of the time; 1 = some of the time; 2 = half of the time; 3 = most of the time; and 4 = all of the time. Seven questions related to visual functioning allow a response of "N/A" (not applicable). The total OSDI was calculated from the raw scores of each of the 12 questions based on the formula: ([sum of scores for all questions answereda] X 100)/([total number of questions answered] X 4). Questions answered with N/A were excluded in the calculation of total OSDI. | Target Population | Posted | Mean | Standard Deviation | score on a scale | Day 14 to Month 3 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | AZR-MD-001 Active | AZR-MD-001 Active will be dosed up to twice weekly. AZR-MD-001 Active: AZR-MD-001 is an active ophthalmic ointment | 1 | 15 | 1 | 15 | 8 | 15 |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Foreign body sensation | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
|
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