New eye drop cocktail aims to soothe dry eyes without preservatives
NCT ID NCT06903741
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
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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
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30 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Jul 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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).
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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
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Group Practice Outpatient Clinic for Specialized Medical Care in Ocular Diseases Dr. Grupchevi Ltd.
Varna, 9002, Bulgaria
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