Dry Eye Disease (DED)
Conditions
Brief summary
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.
Interventions
DEVICET2769
Preservative-free combination of trehalose, sodium hyaluronate and N-acetyl-aspartyl-glutamate
Sponsors
Laboratoires Thea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6 | 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) |
Countries
Bulgaria
Outcome results
None listed