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

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Device: T2769

• Registration Number: NCT05931861
• Lead Sponsor: Laboratoires Thea

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-05
• Study Start: 2023-08-15
• Primary Completion: 2023-12-04
• Study Completion: 2023-12-04
• Status Verified: 2025-01
• Results First Submitted: 2025-01-08
• Results First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Results First Posted: 2025-01-31
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T2769	T2769	One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Ambulatory For Group Practice For Specialized Medical Care For Eye Diseases - Dr. Grupchevi; 🇧🇬 Varna, Bulgaria

Medical Center "Oxycom"; 🇧🇬 Burgas, Bulgaria

Medical Center "Vereya"; 🇧🇬 Stara Zagora, Bulgaria

"Asmp Ob - Ip Glm" Eood; 🇧🇬 Smolyan, Bulgaria

Specialized Ophthalmological Hospital For Active Treatment "Pentagram"; 🇧🇬 Sofia, Bulgaria

Medical Center For Eye Health "Focus"; 🇧🇬 Sofia, Bulgaria