Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New eye drop cocktail aims to soothe dry eyes without preservatives

NCT ID NCT06903741

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This study is testing a new eye drop that combines trehalose, sodium hyaluronate, and NAAGA without preservatives. It will enroll 30 adults with dry eye disease who are either new to treatment or unhappy with their current drops. Over 6 months, researchers will track changes in symptoms and quality of life using a standard questionnaire.

What this could mean

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

Active substance
preservative-free combination of trehalose, sodium hyaluronate, and n-acetyl-aspartyl-glutamate (NAAGA) eye drops
What this could lead to
If it works, this could offer a new, well-tolerated option for people with dry eye disease who are not satisfied with current artificial tears.
What could go wrong
This is a small, early-phase study with only 30 participants and no comparison group, so results may not apply widely. The improvement may be modest or not better than existing treatments.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Oct 2025

Finished

Jul 2026

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.

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: * Men and women aged over 18 years, * Able to give written informed consent prior the initiation of any procedure, * Dry eye diagnosis and/or dry eye symptoms in the last 3 months, * OSDI \>12, * Never been treated with artificial tears or with no artificial tears at least 1 month before the enrolment, or not satisfied with current artificial tears. Exclusion Criteria: Ophthalmic Exclusion Criteria in at least one eye •Far BCVA ≥+0.7 LogMAR (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters). Systemic/non Ophthalmic Exclusion Criteria * Known or suspected hypersensitivity to one of the components of the IMD, * History of or active relevant systemic condition incompatible with the investigation or likely to interfere with the investigation results or the patient safety according to investigator judgment. Specific Exclusion Criteria Regarding Childbearing Potential Women * Pregnant or breast-feeding women, * Childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch). Exclusion Criteria Related to General Conditions * Alcohol addiction and heavy smoker according to investigator's judgement, * Unable to understand the investigation procedures or to give informed consent, * Non-compliant (e.g., not willing to attend a visit or completing the self-questionnaire; way of life interfering with compliance), * Participant in this investigation at the same time as another clinical investigation/study, * Participant in this investigation within the exclusion period of a previous study/investigation with a minimum of one month, * Participant being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee or family member of the investigation sites or of the Sponsor's company. Exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures) •Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Dry eye disease (DED) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Group Practice Outpatient Clinic for Specialized Medical Care in Ocular Diseases Dr. Grupchevi Ltd.

    Varna, 9002, Bulgaria

More trials for these conditions

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