Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.

Study Overview
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Brief Summary
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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.

Official Title
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Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.

Conditions
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Dry Eye

Intervention / Treatment
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* Device: T2769


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2769<br>One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses. | Device: T2769<br>* T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | CLDEQ- score is assessed at Day 1 and Day 36 |