New eye drops aim to soothe dry eye inflammation
NCT ID NCT07245836
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether Thealoz Total eye drops can reduce inflammation and improve symptoms in people with chronic dry eye disease. The drops contain hyaluronic acid for lubrication, plus trehalose and NAAGA to fight inflammation. The trial planned to enroll 30 adults with moderate to severe dry eye, but it was terminated early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Thealoz Total eye drops (hyaluronic acid, trehalose, and NAAGA)
- What this could lead to
- If it works, this could offer a new way to reduce inflammation and improve comfort for people with chronic dry eye.
- What could go wrong
- This was a small, early-terminated Phase 4 trial with only 30 participants. Results may not be reliable or apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
30 people
The number who actually took part.
- Started
-
Jan 2025
- Finished
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Jul 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * Normal ophthalmic findings except dry eye disease * Chronic dry eye defined as longer than six months since diagnosis * OSDI ≥ 22 * Conjunctival Hyperemia≥ Grade 3 (Efron Scale) * Current use of topical lubricants since at least 3 months Exclusion Criteria: Ophthalmic exclusion criteria \- Best far corrected visual acuity \< 1/10 Severe Dry Eye associated with: * Eyelid malposition * Stevens Johnson Syndrome * Corneal dystrophy * Ocular neoplasia * Filamentous keratitis * Corneal neovascularisation * Orbital radiotherapy * Dry eye related to GVHD History of any of the following within last 3 months: * Systemic treatment of dry eye * Systemic treatment of MGD * Isotretinoïde, * Cyclosporine, * Tacrolimus, Siromilus, Pimecrolimus * Punctual plugs History of any of the following within previous six months: * ocular trauma * ocular infection, Ocular allergy History of any of the following within last 12 months: * inflammatory corneal ulcer * Herpetic eye infection or uveitis * Ocular surgery Systemic / non ophthalmic exclusion criteria: \- Known hypersensitivity to any of the components of the medical device under investigation or other study medication Specific exclusion criteria for women: * Pregnant or breast-feeding woman. * Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (i.e. hormonal contraceptives, intra-uterine device, contraceptive implant or condoms) Exclusion criteria related to general conditions \- Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, State of Vienna, 1090, Austria
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