Actively Recruiting
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
Led by Laboratoires Thea · Updated on 2025-11-18
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new preservative-free combination of trehalose, sodium hyaluronate, and N-acetyl-aspartyl-glutamate (NAAGA) for treating dry eye disease (DED). This prospective, non-randomized, non-comparative study aims to assess the performance and safety of this treatment at 3 and 6 months in 30 patients with DED. The study also examines patient compliance and the occurrence of dry eye flares over the treatment period. Participants will use the study device, referred to as T2769, daily throughout the study. The main study period lasts 6 months, during which patients will be monitored at baseline, 3 months, and 6 months. During these visits, researchers will assess symptoms and signs of dry eye disease to evaluate the treatment's effect. Participants will complete self-questionnaires regularly to track symptoms and report any dry eye flare-ups. The primary outcome is the change in the Ocular Surface Disease Index (OSDI) score from baseline to 6 months. Safety, performance, and patient compliance will be closely monitored throughout the study. The total duration of participation is 6 months.
CONDITIONS
Brief 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 before 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 for at least 1 month before enrollment, or not satisfied with current artificial tears
You will not qualify if you...
- Known or suspected allergy to any component of the study device
- History of or active systemic condition that may interfere with study results or patient safety
- Pregnant or breastfeeding women
- Women of childbearing potential not surgically sterilized and not using adequate contraception
- Alcohol addiction or heavy smoking per investigator judgment
- Unable to understand study procedures or give informed consent
- Non-compliant with study requirements such as attending visits or completing questionnaires
- Participation in another clinical study concurrently or within the last month
- Institutionalized individuals due to legal or regulatory orders, psychiatric wards, prisons, or related employment
- Previous, current, or planned use of prohibited treatments or treatment changes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive the preservative-free combination of trehalose, sodium hyaluronate and N-acetyl-aspartyl-glutamate as the study intervention for dry eye disease.
Visits at baseline, 3 months, and 6 months
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
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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