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New eye drops aim to soothe dry, red eyes

NCT ID NCT07007702

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 a new preservative-free eye drop (Thealoz Total) in 30 adults with chronic dry eye and eye redness. Participants used the drops daily for 12 weeks. Researchers measured changes in redness and how satisfied patients felt. The goal was to see if the drops improve comfort and reduce inflammation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trehalose, sodium hyaluronate, and N-Acetyl Aspartyl Glutamic Acid (NAAGA) in preservative-free eye drops
What this could lead to
If successful, this could offer a new option for people with chronic dry eye to reduce redness and feel more comfortable.
What could go wrong
This is a small, early study with only 30 people and no comparison group, so results may not apply to everyone. The drops are meant to ease symptoms, not cure dry eye.

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.

Participants

30 people

The number who actually took part.

Started

Jan 2025

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A total of 30 patients with moderate to severe dry eye disease and associated inflammation.

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 * Sjogren Syndrome * 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. * Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance) * Participation in another clinical study or clinical investigation at the same time as the present investigation * Participation to the present clinical investigation during the exclusion period of another clinical study * Patient already included once in this clinical investigation * Patient under guardianship

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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

  • Universitätsklinik für Klinische Pharmakologie, Allgemeines Krankenhaus Wien

    Vienna, Austria

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