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The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRS01 | Experimental |
| |
| Active comparator | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRS01 | Drug | TRS01 eye drops Dosed four times a day (QID) |
| |
| FDA approved steroid eye drop (masked) |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cell (ACC) Grade = 0 on Day 28 | For FDA submission: the percentage of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells). | 28 days |
| Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28 | For submission to European Medicines Agency (EMA) related countries: the percentage of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Day 1) in ACC Grade on Day 28 in the Study Eye | Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation). ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 28 in the study eye | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lexitas Clinical Trials | Lexitas | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | La Jolla | California | 92093 | United States | ||
| Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41485727 | Result | Chu DS, Tsui E, Rifkin LM, Palestine AG, Rich C, Thorne JE, Haim-Langford D, Milman Z, Fulcher E, Neumann R, DE Smet MD; TRS4Vision Study Group. Dazdotuftide: Novel Treatment for Noninfectious Uveitis with Superior Intraocular Pressure Safety Profile: A Randomized Clinical Trial. Am J Ophthalmol. 2026 Apr;284:78-87. doi: 10.1016/j.ajo.2025.12.034. Epub 2026 Jan 2. |
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3 participants did not receive study medication and therefore were not included in "Started"
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| ID | Title | Description |
|---|---|---|
| FG000 | TRS01 | TRS01: TRS01 eye drops Dosed four times a day (QID) |
| FG001 | Active Comparator | FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 17, 2022 |
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| Drug |
FDA approved steroid eye drop Dosed four times a day (QID) |
|
| Anterior Chamber Cell (ACC) Grade on Day 21 |
Proportion of subjects with ACC Grade=0 on Day 21 in the study eye. |
| 21 days |
| Change From Baseline in ACC Grade on Day 21. | Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation). ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 21 in the study eye | 21 days |
| Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 21 | Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells. | 21 days |
| Los Angeles |
| California |
| 90041 |
| United States |
| Los Angeles 2 | Los Angeles | California | 90095-6984 | United States |
| Aurora | Aurora | Colorado | 80045 | United States |
| Lakewood | Lakewood | Colorado | 80228 | United States |
| Jacksonville | Jacksonville | Florida | 32204 | United States |
| Winter Haven | Winter Haven | Florida | 33800 | United States |
| Marietta | Marietta | Georgia | 30060 | United States |
| Boston | Boston | Massachusetts | 02114 | United States |
| Waltham | Waltham | Massachusetts | 02451 | United States |
| Washington, MO | Washington | Missouri | 63090 | United States |
| Palisades Park | Palisades Park | New Jersey | 07650 | United States |
| Winston-Salem | Winston-Salem | North Carolina | 27157 | United States |
| Nashville | Nashville | Tennessee | 37232 | United States |
| Austin | Austin | Texas | 78712 | United States |
| Plano | Plano | Texas | 75075 | United States |
| San Antonio 2 | San Antonio | Texas | 78238 | United States |
| San Antonio | San Antonio | Texas | 78240 | United States |
| Norfolk | Norfolk | Virginia | 23502 | United States |
| Dijon | Dijon | 21079 | France |
| Lyon | Lyon | 69004 | France |
| Nantes | Nantes | 44000 | France |
| Paris | Paris | 75013 | France |
| Paris | Paris | 75014 | France |
| Bonn | Bonn | 53127 | Germany |
| Düsseldorf | Düsseldorf | 40225 | Germany |
| Freiburg | Freiburg im Breisgau | 79106 | Germany |
| München | München | 80336 | Germany |
| Munster | Münster | 48145 | Germany |
| Tübingen | Tübingen | 72076 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set (FAS)
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| ID | Title | Description |
|---|---|---|
| BG000 | TRS01 | TRS01: TRS01 eye drops Dosed four times a day (QID) |
| BG001 | Active Comparator | FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID) |
| BG002 | 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, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||
| ACC grade | ACC grade 0 - No ACC ACC grade 4 - Severe ACC level ACC = Anterior Chamber Cells | Count of Participants | Participants |
|
| 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 | Anterior Chamber Cell (ACC) Grade = 0 on Day 28 | For FDA submission: the percentage of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells). | Participants with non-missing observations | Posted | Count of Participants | Participants | 28 days |
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| Primary | Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28 | For submission to European Medicines Agency (EMA) related countries: the percentage of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells. | Participants with non-missing observations | Posted | Count of Participants | Participants | 28 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Day 1) in ACC Grade on Day 28 in the Study Eye | Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation). ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 28 in the study eye | Posted | Mean | Standard Deviation | score on a scale | 28 days |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Anterior Chamber Cell (ACC) Grade on Day 21 | Proportion of subjects with ACC Grade=0 on Day 21 in the study eye. | Participants with non-missing observations | Posted | Count of Participants | Participants | 21 days |
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| Secondary | Change From Baseline in ACC Grade on Day 21. | Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation). ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 21 in the study eye | Posted | Mean | Standard Deviation | score on a scale | 21 days |
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| Secondary | Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 21 | Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells. | Participants with non-missing observations | Posted | Count of Participants | Participants | 21 days |
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6 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 | TRS01: TRS01 eye drops Dosed four times a day (QID) | 0 | 90 | 2 | 90 | 7 | 90 |
| EG001 | Active Comparator | FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID) | 0 | 49 | 0 | 49 | 8 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Optic neuritis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment | In non-study eye, unrelated to study drug |
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| Hospitalization Secondary to Diabetic Ketoacidosis and COVID-19 | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment | Unrelated to study drug |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intra ocular pressure increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| COO | Tarsier Pharma Ltd. | +972508371319 | zohar@tarsierpharma.com |
| Jul 24, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Title | Measurements |
|---|---|
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| 45-75 Years |
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| Male |
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| Black or African American |
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| Asian |
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| Unknown |
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| Europe |
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| ACC grade 2 (6-15 cells) |
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