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

Last updated: January 8, 2025
Sponsor: Laboratoires Thea
Overall Status: Completed

Phase

N/A

Condition

Sjogren's Syndrome

Dry Eye Disease

Eyelid Inflammation

Treatment

T2769

Clinical Study ID

NCT05931861
LT2769-003
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 atleast 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

Exclusion

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: ocularrosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia,Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract,Retinal disease.

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: T2769
Phase:
Study Start date:
August 15, 2023
Estimated Completion Date:
December 04, 2023

Connect with a study center

  • Medical Center "Oxycom"

    Burgas,
    Bulgaria

    Site Not Available

  • "Asmp Ob - Ip Glm" Eood

    Smolyan,
    Bulgaria

    Site Not Available

  • Medical Center For Eye Health "Focus"

    Sofia,
    Bulgaria

    Site Not Available

  • Specialized Ophthalmological Hospital For Active Treatment "Pentagram"

    Sofia,
    Bulgaria

    Site Not Available

  • Medical Center "Vereya"

    Stara Zagora,
    Bulgaria

    Site Not Available

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

    Varna,
    Bulgaria

    Site Not Available

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