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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratoires Thea

About this trial

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.

Eligibility criteria

Qualifiers

Men and women aged over 18 years,

Able to give written informed consent prior the initiation of any procedure,

History of dry eye syndrome for at least 3 months,

OSDI ≥13,

Disqualifiers

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.

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) .

Trial design

Treatments tested in this trial

  • T2769

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators