New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye
Recruiting
Phase 4
Interventional Study
Dry Eye Disease (DED)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Laboratoires Thea · Industry
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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 complia…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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,
* Never been treated with artificial tears or with no artificial tears at least 1 month before the …
Contacts