N/A N=34 Treatment

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

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT05931861 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score. — -12.6 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: T2769 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Laboratoires Thea
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score.	-12.6	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05931861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.