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

Thea Pharma

Status: Completed

Conditions: Dry Eye

Treatments: Device: T2769

Study type: Interventional

Funder types: Industry

Identifiers

NCT05931861

LT2769-003

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

T2769

Experimental group

Description:

One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.

Treatment:

Device: T2769