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The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis
.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRS01 low dose | Experimental |
| |
| TRS01 high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRS01 eye drops | Drug | Dosed four times a day (QID) |
| |
| TRS01 eye drops |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Both Systemic and Ocular Adverse Events | Number of patients experiencing Adverse Events during the study | 10 weeks |
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Inclusion Criteria:
An eligible subject must have:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palisades Park | Palisades Park | New Jersey | 07650 | United States | ||
| San Antonio |
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| ID | Title | Description |
|---|---|---|
| FG000 | TRS01 Low Dose | TRS01 eye drops: Dosed four times a day (QID) |
| FG001 | TRS01 High Dose | TRS01 eye drops: Dosed four times a day (QID) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TRS01 Low Dose | TRS01 eye drops: Dosed four times a day (QID) |
| BG001 | TRS01 High Dose | TRS01 eye drops: Dosed four times a day (QID) |
| 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 | Assessment of Both Systemic and Ocular Adverse Events | Number of patients experiencing Adverse Events during the study | Posted | Count of Participants | Participants | 10 weeks |
|
|
10 weeks
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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 | TRS01 Low Dose | TRS01 eye drops: Dosed four times a day (QID) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| COO | Tarsier Pharma | +972508371319 | zohar@tarsierpharma.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 | Mar 5, 2020 | Aug 16, 2023 | Prot_SAP_000.pdf |
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| Drug |
Dosed four times a day (QID) |
|
| San Antonio |
| Texas |
| 78240 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Iris color | Count of Participants | Participants |
|
| Anterior Chamber Cell Grade in the study eye | A scale of 0 to 4, where Grade 0 = No ACC and Grade 4 = Severe ACC level. i.e., higher scores are considered worse outcomes | Count of Participants | Participants |
|
| Disease course | Count of Participants | Participants |
|
|
|
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | TRS01 High Dose | TRS01 eye drops: Dosed four times a day (QID) | 0 | 8 | 0 | 8 | 5 | 8 |
|
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment | Judged by PI to be unrelated to study drug |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Instillation site pain | General disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Fatigue | General disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Nausea | Gastrointestinal disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Iritis | Eye disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
|
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Headache | Nervous system disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Hordeolum | Infections and infestations | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Syphilis | Infections and infestations | Systematic Assessment | Judged by PI to be unrelated to study drug |
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| Vitamin D deficiency | Metabolism and nutrition disorders | Systematic Assessment | Judged by PI to be unrelated to study drug |
|
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment | Judged by PI to be unrelated to study drug |
|
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