Dry Eye Syndrome
Conditions
Brief summary
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.
Interventions
DEVICET2769
Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.
DEVICEHylo-Forte®
Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria (At Screening visit): * Informed consent signed and dated (obtained prior to initiating any procedures). * Patient aged ≥18 years old. * Persistence of dry eye syndrome, despite artificial tears use in the previous month prior to the screening visit Main
Exclusion criteria
(At both Screening and Randomisation visits): * Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 letters Early Treatment Diabetic Retinopathy Study (ETDRS)). * Patient with previous or current ophthalmic condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score). | Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36 | 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) |
Countries
Czechia, Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T2769 Test device: T2769 (Thealoz® Total) T2769 is a sterile, phosphate-free and pH neutral solution. It contains Trehalose, Sodium Hyaluronate (SH) and Naaga. | 36 |
| 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. | 38 |
| Total | 74 |
Baseline characteristics
| Characteristic | Hylo-Forte | Total | T2769 |
|---|---|---|---|
| Age, Continuous | 47.5 years STANDARD_DEVIATION 14.44 | 50.6 years STANDARD_DEVIATION 14.68 | 53.9 years STANDARD_DEVIATION 14.42 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Czechia | 3 participants | 9 participants | 6 participants |
| Region of Enrollment Hungary | 35 participants | 65 participants | 30 participants |
| Sex: Female, Male Female | 30 Participants | 57 Participants | 27 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 38 |
| other Total, other adverse events | 0 / 36 | 0 / 38 |
| serious Total, serious adverse events | 0 / 36 | 0 / 38 |
Outcome results
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)
Time frame: Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36
Population: Day 1-Baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| T2769 | To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score). | -1.3 score on a scale |
| Hylo-Forte | To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score). | -1.2 score on a scale |