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| Name | Class |
|---|---|
| Syneos Health | OTHER |
| Cliantha Research | OTHER |
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AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)
AZ201801 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 sequentially overlapping cohorts evaluating the safety, efficacy and tolerability of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZR-MD-001 Low Dose | Experimental | AZR-MD-001 Low Dose will be dosed up to once daily. |
|
| AZR-MD-001 Mid Dose | Experimental | AZR-MD-001 Mid Dose will be dosed up to once daily. |
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| AZR-MD-001 High Dose | Experimental | AZR-MD-001 High Dose will be dosed up to once daily. |
|
| AZR-MD-001 Vehicle | Sham Comparator | AZR-MD-001 Vehicle will be dosed up to once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZR-MD-001 Low Dose | Drug | AZR-MD-001 is an ophthalmic ointment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Meibomian Glands Yielding Liquid Secretion (MGYLS) | Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal) | Value at month 3 minus value at baseline |
| Ocular Surface Disease Index (OSDI) Total Score | Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal) | Value at month 3 minus value at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie L Watson | Save Sight Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Eye Institute | Chatswood | New South Wales | 2067 | Australia | ||
| Eye Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37478969 | Derived | Watson SL, Jones LW, Stapleton F, Hinds M, Ng A, Tan J, Alster Y, Bosworth C, Rafaeli O, DePuy V; CELESTIAL STUDY Group. Efficacy and safety of AZR-MD-001 selenium sulfide ophthalmic ointment in adults with meibomian gland dysfunction: A vehicle-controlled, randomized clinical trial. Ocul Surf. 2023 Jul;29:537-546. doi: 10.1016/j.jtos.2023.07.002. Epub 2023 Jul 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZR-MD-001 Low Dose | AZR-MD-001 Low Dose was dosed twice weekly. AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment |
| FG001 | AZR-MD-001 Mid Dose | AZR-MD-001 Mid Dose was dosed twice weekly. AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 |
|
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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 19, 2021 | Oct 16, 2023 |
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| AZR-MD-001 Mid Dose |
| Drug |
AZR-MD-001 is an ophthalmic ointment |
|
| AZR-MD-001 High Dose | Drug | AZR-MD-001 is an ophthalmic ointment |
|
| AZR-MD-001 Vehicle | Drug | AZR-MD-001 is a vehicle ophthalmic ointment |
|
| Sydney |
| New South Wales |
| 2000 |
| Australia |
| Sydney Eye Hospital | Sydney | New South Wales | 2000 | Australia |
| School of Optometry and Vision Science, University of New South Wales | Sydney | New South Wales | 2052 | Australia |
| Queensland University of Technology | Brisbane | Queensland | 4059 | Australia |
| Queensland Eye Institute | South Brisbane | Queensland | 4101 | Australia |
| Ophthalmic Trials Australia | Teneriffe | Queensland | 4005 | Australia |
| Eye Laser Specialists | Armadale | Victoria | 3143 | Australia |
| Bendigo Eye Clinic | Bendigo | Victoria | 3550 | Australia |
| Waverley Eye Clinic | Glen Waverley | Victoria | 3150 | Australia |
| Downie Laboratory, Department of Optometry and Vision Sciences | Melbourne | Victoria | 3053 | Australia |
| Deakin University | Waurn Ponds | Victoria | 3216 | Australia |
| Seema Eye Care | Calgary | Alberta | AB T2V 4J2 | Canada |
| FYI Doctors | Campbell River | British Columbia | Canada |
| VCH Research Institute. | Vancouver | British Columbia | V5Z 3N8 | Canada |
| Ophthalmology | Vancouver | British Columbia | V6H1H2 | Canada |
| Ocean Optometry | Halifax | Nova Scotia | NS B3J 1J7 | Canada |
| Miller Optometry | Halifax | Nova Scotia | Canada |
| Prism Eye Institute | Brampton | Ontario | 6Y 4M3 | Canada |
| Cliantha Research | Mississauga | Ontario | L4W 1A4 | Canada |
| Precision Cornea Centre | Ottawa | Ontario | K1G 3Y7 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| FYI Doctors | Toronto | Ontario | L3R 1N1 | Canada |
| Healthpoint | Toronto | Ontario | L6T 0G1 | Canada |
| Eyes on Sheppard Clinic | Toronto | Ontario | M2N3A1 | Canada |
| Toronto Eye Care | Toronto | Ontario | M4W 0A7 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| School of Optometry & Vision Science, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
| University of Auckland | Auckland | 1023 | New Zealand |
| AucklandEye | Auckland | 1050 | New Zealand |
| FG002 | AZR-MD-001 High Dose | AZR-MD-001 High Dose was dosed twice weekly. AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment |
| FG003 | AZR-MD-001 Vehicle | AZR-MD-001 Vehicle was dosed twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment |
| COMPLETED |
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| NOT COMPLETED |
|
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| Stage 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1: AZR-MD-001 Low Dose | AZR-MD-001 Low Dose was dosed twice weekly. AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment |
| BG001 | Stage 1: AZR-MD-001 Mid Dose | AZR-MD-001 Mid Dose was dosed twice weekly. AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment |
| BG002 | Stage 1: AZR-MD-001 High Dose | AZR-MD-001 High Dose was dosed twice weekly. AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment |
| BG003 | Stage 1: AZR-MD-001 Vehicle | AZR-MD-001 Vehicle was dosed twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment |
| BG004 | Stage 2: AZR-MD-001 Mid Dose | AZR-MD-001 Mid Dose was dosed twice weekly. AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment |
| BG005 | Stage 2: AZR-MD-001 High Dose | AZR-MD-001 High Dose was dosed twice weekly. AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment |
| BG006 | Stage 2: AZR-MD-001 Vehicle | AZR-MD-001 Vehicle was dosed twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Meibomian Glands Yielding Liquid Secretion (Primary Sign Endpoint) | Count of the number of open glands on the inferior lid ranging from 0 (no open glands) to 15 (total number of evaluated glands) | Mean | Standard Deviation | Gland Count (0 to 15) |
| ||||||||||||||
| OSDI Total Score (Primary Symptom Endpoint) | The total score on the OSDI ranges from 0 (normal) to 100 (severe disease) | Mean | Standard Deviation | Total Score (0 to 100) |
|
| 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 | Meibomian Glands Yielding Liquid Secretion (MGYLS) | Change from Baseline in MGYLS. The MGYLS can range from 0 (abnormal) to 15 (normal) | Posted | Mean | Standard Deviation | Number of Open Glands | Value at month 3 minus value at baseline |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Ocular Surface Disease Index (OSDI) Total Score | Change from Baseline in OSDI Total Score. The OSDI Total Score can range from 100 (highly abnormal) to 0 (Normal) | Posted | Mean | Standard Deviation | Scores on a Scale | Value at month 3 minus value at baseline |
|
3 months
AEs were classified into system organ class (SOC) and preferred term (PT) using MedDRA version 23.0 or higher. Treatment-emergent adverse events (TEAEs) were defined as events beginning or worsening on or after the planned first dose of study medication.
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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 | Stage 1: AZR-MD-001 Low Dose | AZR-MD-001 Low Dose was dosed twice weekly. AZR-MD-001 Low Dose: AZR-MD-001 is an ophthalmic ointment | 0 | 9 | 0 | 9 | 2 | 9 |
| EG001 | Stage 1: AZR-MD-001 Mid Dose | AZR-MD-001 Mid Dose was dosed twice weekly. AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment | 0 | 27 | 0 | 27 | 13 | 27 |
| EG002 | Stage 1: AZR-MD-001 High Dose | AZR-MD-001 High Dose was dosed twice weekly. AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment | 0 | 24 | 2 | 24 | 14 | 24 |
| EG003 | Stage 1: AZR-MD-001 Vehicle | AZR-MD-001 Vehicle was dosed twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment | 0 | 16 | 0 | 16 | 4 | 16 |
| EG004 | Stage 2: AZR-MD-001 Mid Dose | AZR-MD-001 Mid Dose was dosed twice weekly. AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment | 0 | 82 | 1 | 82 | 54 | 82 |
| EG005 | Stage 2: AZR-MD-001 High Dose | AZR-MD-001 High Dose was dosed twice weekly. AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment | 0 | 83 | 1 | 83 | 60 | 83 |
| EG006 | Stage 2: AZR-MD-001 Vehicle | AZR-MD-001 Vehicle was dosed twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment | 0 | 80 | 2 | 80 | 8 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment | pneumonia |
|
| Pericarditis | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment | Pericarditis |
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| Thyroid mass | Endocrine disorders | MedDRA version 25.0 | Systematic Assessment | Thyroid mass |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment | Post procedural haemorrhage |
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| n intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| ocular toxicity | Eye disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Application site pain |
|
| Lacrimation increased | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Lacrimation increased |
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| Punctate keratitis | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Punctate keratitis |
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| Vital dye staining cornea present | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Vital dye staining cornea present |
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| Eye pain | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Eye pain |
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| Eye irritation | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Eye irritation |
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| Application site reaction | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Application site reaction |
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| Foreign body sensation | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Foreign body sensation |
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| Administration site reaction | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Administration site reaction |
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| Photophobia | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Photophobia |
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| Eye inflammation | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Eye inflammation |
|
| Application site irritation | Eye disorders | MedDRA version 25.0 | Systematic Assessment | Application site irritation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Bosworth | Azura Ophthalmics | 17145598435 | charles.bosworth@azuraophthalmics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2022 | Oct 16, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| Protocol Violation |
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| Lost to Follow-up |
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| Withdrawal by Subject |
|
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
AZR-MD-001 Mid Dose was dosed twice weekly. AZR-MD-001 Mid Dose: AZR-MD-001 is an ophthalmic ointment |
| OG005 | Stage 2: AZR-MD-001 High Dose | AZR-MD-001 High Dose was dosed twice weekly. AZR-MD-001 High Dose: AZR-MD-001 is an ophthalmic ointment |
| OG006 | Stage 2: AZR-MD-001 Vehicle | AZR-MD-001 Vehicle was dosed twice weekly. AZR-MD-001 Vehicle: AZR-MD-001 is a vehicle ophthalmic ointment |
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