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The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2259 | Experimental | 1 drop in each eye 2 to 4 times daily |
|
| Vismed Multi | Active Comparator | 1 drop in each eye 2 to 4 times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2259 | Device | Sodium Hyaluronate and Trehalose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15) | Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome) | Baseline and Day 35 |
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Main inclusion Criteria:
Main exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.H.N.O des XV-XX | Paris | 75012 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | T2259 | 1 drop in each eye 2 to 4 times daily 3 months treatment period lasted from randomisation visit (Day 1 ; Visit #2) to the final visit (Day 84 (7 days) ; Visit #5) |
| FG001 | Vismed Multi | 1 drop in each eye 2 to 4 times daily 3 months treatment period lasted from randomisation visit (Day 1 ; Visit #2) to the final visit (Day 84 (7 days) ; Visit #5) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
FAS population
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| ID | Title | Description |
|---|---|---|
| BG000 | T2259 | 1 drop in each eye 2 to 4 times daily T2259 |
| BG001 | Vismed Multi | 1 drop in each eye 2 to 4 times daily Vismed multi |
| 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 | Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15) | Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome) | PP population | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 35 |
|
15 weeks from D-10 to D84 (±7 days)
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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 | T2259 | 1 drop in each eye 2 to 4 times daily | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA version 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corentin Le Camus | Laboratoires Thea | 0680382020 | +33 | corentin.lecamus@theapharma.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 | Jan 3, 2020 | Oct 31, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2021 | Jun 14, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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investigator-masked
| Vismed multi | Device | HA |
|
|
| Covid-19 pandemic |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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|
| 50 |
| 0 |
| 50 |
| 4 |
| 50 |
| EG001 | Vismed Multi | 1 drop in each eye 2 to 4 times daily | 0 | 51 | 1 | 51 | 0 | 51 |
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