Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.
The investigation is defined as a post-market stage. The clinical investigation design is confirmatory.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2769 | Experimental | Hyaluronic acid, Trehalose, Naaga Route of administration: topical, ocular use |
|
| Hylo-Forte® | Active Comparator | Hyaluronic acid Route of administration: topical, ocular use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2769 | Device | Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score). | The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford Scale 0-15 grading scheme at D36 in the study eye. Minimum value is 0 (better case) and maximum value is 15 (worse case) | Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36 |
Not provided
Not provided
Main Inclusion Criteria (At Screening visit):
Main Exclusion Criteria (At both Screening and Randomisation visits):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OFTEX, s.r.o. | Prague | 11800 | Czechia | |||
| Axon Clinical, s.r.o. |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | T2769 | T2769 (Thealoz® Total) T2769 is a sterile, phosphate-free and pH neutral solution. It contains Trehalose, Sodium Hyaluronate (SH) and Naaga. |
| FG001 | Hylo-Forte | HYLO-FORTE® is a sterile, phosphate and preservative-free solution for ocular use containing sodium hyaluronate, citric acid anhydrous, sodium citrate and sorbitol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T2769 | Test device: T2769 (Thealoz® Total) T2769 is a sterile, phosphate-free and pH neutral solution. It contains Trehalose, Sodium Hyaluronate (SH) and Naaga. |
| BG001 | Hylo-Forte |
| 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 | To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score). | The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford Scale 0-15 grading scheme at D36 in the study eye. Minimum value is 0 (better case) and maximum value is 15 (worse case) | Day 1-Baseline | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36 |
|
7 weeks from D-10 to D36 (+3 days)
AE: Any untoward medical occurrence, unintended disease or injury or untoward clinical signs in subjects, users or other persons whether or not related to IMD.
This includes events related to IMD or comparator, events related to the procedures involved, For users or other persons, this definition is restricted to events related to use of the IMD or comparator.
Adverse event is an incident. REPORTING: Any incident must report to Sponsor within 24 hours of awareness using incident form.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T2769 | T2769 (Thealoz® Total) T2769 is a sterile, phosphate-free and pH neutral solution. It contains Trehalose, Sodium Hyaluronate (SH) and Naaga. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corentin LE CAMUS | Laboratoires Théa | 0033 473989604 | Corentin.LECAMUS@theapharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2024 | Dec 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2025 | Dec 5, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hylo-Forte® |
| Device |
Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily. |
|
| Prague |
| 15000 |
| Czechia |
| Ganglion Medical Center | Pécs | Baranya | 7621 | Hungary |
| Ermellek Egeszsegcentrum | Létavértes | Hb | 4281 | Hungary |
HYLO-FORTE® is a sterile, phosphate and preservative-free solution for ocular use containing sodium hyaluronate, citric acid anhydrous, sodium citrate and sorbitol.
| BG002 | Total | Total of all reporting groups |
| 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 |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Hylo-Forte | HYLO-FORTE® is a sterile, phosphate and preservative-free solution for ocular use containing sodium hyaluronate, citric acid anhydrous, sodium citrate and sorbitol. | 0 | 38 | 0 | 38 | 0 | 38 |
Not provided
Not provided