NCT06655441 The Effects of 3% Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function
| NCT ID | NCT06655441 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Southern California College of Optometry at Marshall B. Ketchum University |
| Condition | Dry Eye Disease (DED) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to evaluate the effects of trehalose, an ingredient found in commercially available artificial tears, on the corneal barrier function. The investigators will assess corneal dryness and measure the relative corneal epithelial "barrier" function (the degree to which the cornea can prevent penetration of sodium fluorescein dye into the eye) after using eye drops that contain 3% trehalose for one month.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06655441 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Disease (DED). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06655441 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06655441 currently recruiting?
Yes, NCT06655441 is actively recruiting participants. Contact the research team at sansari@ketchum.edu for enrollment information.
Where is the NCT06655441 trial being conducted?
This trial is being conducted at Fullerton, United States.
Who is sponsoring the NCT06655441 clinical trial?
NCT06655441 is sponsored by Southern California College of Optometry at Marshall B. Ketchum University. The trial plans to enroll 30 participants.