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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004327-20 | EudraCT Number | ||
| Grant Agreement Number 879598 | Other Grant/Funding Number | European Union's Horizon 2020 |
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The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRS01 low dose | Experimental |
| |
| TRS01 medium dose | Experimental |
| |
| TRS01 high dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRS01 eye drops | Drug | Dosed 4 times a day (QID) |
| |
| TRS01 eye drops |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Both Systemic and Ocular Adverse Events | Number of adverse events that occurred during the study | 14 days |
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Inclusion Criteria:
Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inglewood | Inglewood | California | 90302 | United States | ||
| Petaluma |
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| ID | Title | Description |
|---|---|---|
| FG000 | TRS01 Low Dose | TRS01 eye drops: Dosed 4 times a day (QID) |
| FG001 | TRS01 Medium Dose | TRS01 eye drops: Dosed QID |
| FG002 | TRS01 High Dose | TRS01 eye drops: Dosed QID |
| FG003 | Placebo | Placebo eye drops: Dosed QID |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TRS01 Low Dose | TRS01 eye drops: Dosed 4 times a day (QID) |
| BG001 | TRS01 Medium Dose | TRS01 eye drops: Dosed QID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Assessment of Both Systemic and Ocular Adverse Events | Number of adverse events that occurred during the study | All randomized subjects who took at least 1 dose of study drug | Posted | Number | Number of TEAE | 14 days |
|
14 days
Safety Population: all randomized subjects who took at least 1 dose of study drug. Adverse events were collected from the signing of the Informed Consent Form (Screening) to the end of study (Day 15 or Early Termination).
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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 4 times a day (QID) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zohar Milman | Tarsier Pharma | +972-50-8371319 | Zohar Milman <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 6, 2020 | Sep 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Drug |
Dosed QID |
|
| TRS01 eye drops | Drug | Dosed QID |
|
| Placebo eye drops | Drug | Dosed QID |
|
| Petaluma |
| California |
| 94954 |
| United States |
| Washington, MO | Washington | Missouri | 63090 | United States |
| New York | New York | New York | 10013 | United States |
| Cincinnati | Cincinnati | Ohio | 45242 | United States |
| BG002 |
| TRS01 High Dose |
TRS01 eye drops: Dosed QID |
| BG003 | Placebo | Placebo eye drops: Dosed QID |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 | The following scoring scale for anterior chamber cells was used: 0 = No cells seen
| Count of Participants | Participants |
|
| OG003 | Placebo | Placebo eye drops: Dosed QID |
|
|
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | TRS01 Medium Dose | TRS01 eye drops: Dosed QID | 0 | 10 | 0 | 10 | 2 | 10 |
| EG002 | TRS01 High Dose | TRS01 eye drops: Dosed QID | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Placebo | Placebo eye drops: Dosed QID | 0 | 10 | 0 | 10 | 0 | 10 |
| Device Dislocation | Product Issues | Systematic Assessment |
|
There is an agreement between Principal Investigators (and their Institutions) and the Sponsor that restricts the PI's rights to discuss or publish results of this study without the prior written consent of the study Sponsor.