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New eye drops aim to soothe dry eye inflammation

NCT ID NCT07245836

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.