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

January 8, 2025 updated by: Laboratoires Thea

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria
        • Medical Center "Oxycom"
      • Smolyan, Bulgaria
        • "Asmp Ob - Ip Glm" Eood
      • Sofia, Bulgaria
        • Medical Center For Eye Health "Focus"
      • Sofia, Bulgaria
        • Specialized Ophthalmological Hospital For Active Treatment "Pentagram"
      • Stara Zagora, Bulgaria
        • Medical Center "Vereya"
      • Varna, Bulgaria
        • Ambulatory For Group Practice For Specialized Medical Care For Eye Diseases - Dr. Grupchevi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T2769
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
T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score.
Time Frame: 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.
CLDEQ- score is assessed at Day 1 and Day 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Investigators

  • Principal Investigator: Christina Grupcheva, Professor, Individual Practice for Specialized Ophthalmology Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Actual)

December 4, 2023

Study Completion (Actual)

December 4, 2023

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2769-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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