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

NCT05931861 | Completed Results

• 1 other identifier: LT2769-003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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.

  CLDEQ- score is assessed at Day 1 and Day 36

Study Arms (1)

T2769

EXPERIMENTAL

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

Interventions

T2769 DEVICE

T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.

T2769

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (6)

Medical Center "Oxycom"

Burgas, Bulgaria

Location

"Asmp Ob - Ip Glm" Eood

Smolyan, Bulgaria

Location

Medical Center For Eye Health "Focus"

Sofia, Bulgaria

Location

Specialized Ophthalmological Hospital For Active Treatment "Pentagram"

Sofia, Bulgaria

Location

Medical Center "Vereya"

Stara Zagora, Bulgaria

Location

Ambulatory For Group Practice For Specialized Medical Care For Eye Diseases - Dr. Grupchevi

Varna, Bulgaria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Affairs Director
• Organization: Laboratoires Théa

Corentin.LECAMUS@theapharma.com

0473981436

Study Officials

• Christina Grupcheva, Professor

  Individual Practice for Specialized Ophthalmology Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 5, 2023
• Study Start: August 15, 2023
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Locations

BU (6)