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

NCT05931861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-01-31

Study results available
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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

Interventions

DEVICE

T2769

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

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Principal Investigators

  • Christina Grupcheva, Professor · Individual Practice for Specialized Ophthalmology Care

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2023-12-04
Completion
2023-12-04

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05931861 on ClinicalTrials.gov