Completed

NCT Number: NCT06903741

New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye

The goal of this prospective, non-randomized, non-comparative, monocentric PMCF study is to assess the performance of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA on DED at 6 months in 30 patients having dry eye disease.

The main questions it aims to answer are:

* To assess the performance and safety of T2769 at 3 months and 6 months. * To assess patient compliance to therapy. * To assess the occurrence of dry eye flares. Participants will be asked to use T2769 on a daily basis and complete a self-questionnaire throughout the study.

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Group Practice Outpatient Clinic for Specialized Medical Care in Ocular Diseases Dr. Grupchevi Ltd.

Varna, 9002, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women aged over 18 years,
Able to give written informed consent prior the initiation of any procedure,
Dry eye diagnosis and/or dry eye symptoms in the last 3 months,
OSDI >12,
Never been treated with artificial tears or with no artificial tears at least 1 month before the enrolment, or not satisfied with current artificial tears.

Exclusion criteria

Ophthalmic Exclusion Criteria in at least one eye •Far BCVA ≥+0.7 LogMAR (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters).

Systemic/non Ophthalmic Exclusion Criteria

Known or suspected hypersensitivity to one of the components of the IMD,
History of or active relevant systemic condition incompatible with the investigation or likely to interfere with the investigation results or the patient safety according to investigator judgment.

Specific Exclusion Criteria Regarding Childbearing Potential Women

Pregnant or breast-feeding women,
Childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch).

Exclusion criteria

Related to General Conditions

Alcohol addiction and heavy smoker according to investigator's judgement,
Unable to understand the investigation procedures or to give informed consent,
Non-compliant (e.g., not willing to attend a visit or completing the self-questionnaire; way of life interfering with compliance),
Participant in this investigation at the same time as another clinical investigation/study,
Participant in this investigation within the exclusion period of a previous study/investigation with a minimum of one month,
Participant being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee or family member of the investigation sites or of the Sponsor's company.

Exclusion criteria

related to previous and concomitant treatments (medications/non-medicinal therapies/procedures)

•Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).

Treatment and study plan

T2769

Device

Preservative-free combination of trehalose, sodium hyaluronate and N-acetyl-aspartyl-glutamate

Primary outcomes

Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6

Time frame: at baseline, at 3 months, at 6 months

Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6 OSDI is a 12-item scale with total score from 0 to 100 (Mild 13-22; moderate 23-32; severe 33-100)

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

Effect of a New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) on Dry Eye Disease and Patient Quality of Life

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 1, 2025
Registry last updated: Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed