Can a sugar in eye drops strengthen your Eyes' defenses?
NCT ID NCT06655441
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a special ingredient called trehalose, found in some artificial tears, can improve the eye's natural barrier function in people with dry eye disease. About 30 adults with moderate-to-severe dry eye will use the drops for one month. Researchers will measure how well the cornea keeps out a harmless dye to see if the barrier gets stronger.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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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.
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: * Adult subjects, \> age 18 years, with moderate-to-severe dry eye, defined as fitting criteria for dry eye stages 3 or 4 of the MGD Workshop Management and Treatment subcommittee report. * Subjects must have normal eyelid position and closure. * For enrollment as aqueous tear deficiency, subjects must have a Schirmer I result of \< 5.0 mm wetting in 5 minutes without anesthesia. Exclusion Criteria: * History or evidence of ocular or intraocular surgery in either eye within the past twelve months. LASIK and other kerato-refractive procedure patients can qualify if the most recent surgery or enhancement was 12 or more months prior. * History or evidence of serious ocular trauma in either eye within the past six months. * History of hypersensitivity to any component of the study medications. * History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye. * History or evidence of active ocular allergy. * Females who are pregnant, nursing, or planning a pregnancy during the study. * Evidence of greater than mild eyelid deformity (e.g., ectropion, entropion, ptosis). * Use of concomitant topical ocular medications during the study duration. * Individuals using systemic steroids, immunosuppressive agents and/or anti-cholinergic (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in the study if they have not been on a stable dosing regimen for a minimum of 30 days prior to the visit. * Individuals with uncontrolled diabetes or history or evidence of peripheral neuropathy. * Active intraocular inflammatory conditions such as iritis. * Individuals wearing rigid gas permeable or scleral contact lenses within the previous six months of enrollment. Subjects can have worn soft lenses, but not within one month prior to enrollment. * Individuals using punctual plugs inserted within 30 days of study start.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Marshall B. Ketchum University
RECRUITINGFullerton, California, 92831, United States
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Other studies related to the condition(s) this trial covers.
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- Can acne drug harm the eyes? new study investigates
- Which eye drop wins the dry eye battle? a Head-to-Head test
- Can a new eye drop soothe dry eye? a trial puts TRYPTYR to the test