Actively Recruiting
New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye
Led by Laboratoires Thea · Updated on 2025-11-18
30
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Ocular Surface Disease Index (OSDI) score of 13 or higher
- Never treated with artificial tears or no artificial tears used for at least 1 month before enrollment, or not satisfied with current artificial tears
You will not qualify if you...
- Known or suspected hypersensitivity to any component of the investigational medical device
- History of or active systemic conditions that could interfere with study results or patient safety
- Pregnant or breastfeeding women
- Women of childbearing potential not surgically sterilized and not using effective contraception
- Alcohol addiction or heavy smoking as judged by the investigator
- Unable to understand study procedures or provide informed consent
- Non-compliance with study requirements or unwillingness to complete self-questionnaires
- Participation in another clinical study during this investigation
- Participation in another clinical study within one month before this study
- Institutionalized individuals due to legal or regulatory order, or inmates of psychiatric wards, prisons, or state institutions
- Employees or family members of the study sites or sponsor
- Previous, current, or anticipated use of prohibited treatments or treatment regimen changes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Group Practice Outpatient Clinic for Specialized Medical
Varna, Bulgaria, 9002
Actively Recruiting
Research Team
M
Medical Affairs Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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