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To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment.
To evaluate the performance and safety of T2769 versus Vismed® Multi.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2769 | Experimental | 1 drop in each eye, 3 to 6 times daily |
|
| Vismed® Multi | Active Comparator | 1 drop in each eye, 3 to 6 times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2769 | Device | T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15) | Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome) | Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric CHIAMBARETTA, Prof. | Individual Practice for Specialized Ophthalmology Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriel-Montpied University Hospital | Clermont-Ferrand | 63003 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | T2769 | 1 drop in each eye, 3 to 6 times daily T2769: T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle. |
| FG001 | Vismed® Multi | 1 drop in each eye, 3 to 6 times daily Vismed® Multi: Hyaluronic acid |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT set
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| ID | Title | Description |
|---|---|---|
| BG000 | T2769 | 1 drop in each eye, 3 to 6 times daily T2769: Sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle. |
| BG001 | Vismed® Multi | 1 drop in each eye, 3 to 6 times daily Vismed® Multi: Hyaluronic acid |
| 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 : Minimum 0- Maximum 15) | Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome) | Posted | Mean | Standard Deviation | score on a scale | Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36 |
|
7 weeks from D-10 to D36 (+3 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 | T2769 | 1 drop in each eye, 3 to 6 times daily T2769: T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Limb fracture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Non-systematic Assessment | Hand phalanx fracture |
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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 | Jun 15, 2023 | Sep 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2024 | Sep 17, 2025 | 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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Change from baseline in the study eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)
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| Vismed® Multi |
| Device |
Hyaluronic acid |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| divers reasons(patient or doctor not available for visit...), |
|
| 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 | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 125 |
| 0 |
| 125 |
| 0 |
| 125 |
| EG001 | Vismed® Multi | 1 drop in each eye, 3 to 6 times daily Vismed® Multi: Hyaluronic acid | 0 | 126 | 2 | 126 | 0 | 126 |
|
| haematuria | Renal and urinary disorders | MedDRA version 26.0 | Non-systematic Assessment | Macroscopic haematuria |
|
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