Dry Eye
Conditions
Brief summary
This is a confirmatory clinical investigation. The objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes. The hypotheses are that T2769 improves dry eye symptomatology (e.g. decrease in CLDEQ-8 score, in OSDI score, ocular discomfort assessed by VAS) and signs (e.g. increase in Schirmer and TBUT, decrease in Oxford score) at D36, in comparison to baseline. The primary objective of this investigation is to assess the performance of T2769 in contact lens wearers with dry eye symptoms in terms of change from baseline (Day 1) to Day 36 (Final visit) in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.
Interventions
DEVICET2769
T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.
Sponsors
Laboratoires Thea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Informed consent signed and dated * Patient aged ≥ 18 years old * Well fitted contact lenses (CL) according to the investigator judgement * Daily wearer of any type of CL for a minimum of 5 days/week for 6 hours/day over at least the last month and is willing to continue to do so during the study * Patient with an Ocular Surface Disease Index (OSDI) score ≥ 18 * CLDEQ-8 score ≥ 12 Main
Exclusion criteria
* Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters). * Severe blepharitis * Severe Meibomian gland dysfunction * Palpebral or nasolacrimal disorders * Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score. | CLDEQ- score is assessed at Day 1 and Day 36 | The primary endpoint is the change from baseline (Day 1) to Day 36 in the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score. CLDEQ-8 consists of 8 questions designed to measure dry eye symptoms specifically related to the use of contact lenses. The total score is obtained by adding the scores obtained for each answer. The final score is ranging from 1 to 37. 37 is the worst score. |
Countries
Bulgaria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T2769 One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.
T2769: T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | T2769 | — |
|---|---|---|
| Age, Continuous | 39.7 years STANDARD_DEVIATION 14 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score.
The primary endpoint is the change from baseline (Day 1) to Day 36 in the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score. CLDEQ-8 consists of 8 questions designed to measure dry eye symptoms specifically related to the use of contact lenses. The total score is obtained by adding the scores obtained for each answer. The final score is ranging from 1 to 37. 37 is the worst score.
Time frame: CLDEQ- score is assessed at Day 1 and Day 36
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T2769 | Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score. | -12.6 score on a scale | Standard Deviation 5 |