3% trehalose eye drops for corneal barrier protection

The Effects of 3% Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function

This trial will test whether using 3% trehalose eye drops for one month improves corneal barrier function in adults with moderate-to-severe dry eye.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University (Academic / other)
• Locations: 1 site (Fullerton, California)
• Trial ID: NCT06655441 on ClinicalTrials.gov

What this trial studies

This is a randomized contralateral eye-controlled trial enrolling adults with moderate-to-severe dry eye, where one eye receives a 3% trehalose ophthalmic solution and the other eye receives sterile buffered saline. Participants undergo standardized clinical examinations at baseline and after one month, including symptom questionnaires, tear and ocular surface measurements, Schirmer testing when applicable, and fluorometry to measure sodium fluorescein penetration. The primary outcome focuses on relative corneal epithelial barrier function as indicated by dye penetration, with secondary assessments of signs and symptoms of dry eye. All treatments are administered topically and compared within-subject to minimize variability.

Who should consider this trial

Good fit: Ideal candidates are adults (18+) with moderate-to-severe dry eye (stage 3 or 4), normal eyelid position and closure, and meeting Schirmer I criteria for aqueous tear deficiency when applicable.

Not a fit: People with recent ocular surgery or serious ocular trauma, active viral or other ocular infections, known hypersensitivity to study components, or only mild dry eye are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, this could reduce corneal dye penetration and improve ocular surface health and symptoms for people with moderate-to-severe dry eye.

How similar studies have performed: Smaller clinical reports and commercial experience with trehalose-containing tears suggest protective effects on the ocular surface, but randomized contralateral evidence is limited.

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.

Where this trial is running

Fullerton, California

• Marshall B. Ketchum University — Fullerton, California, United States (Recruiting)

Study contacts

• Study coordinator: Shora Ansari, OD, MS

Conditions Dry Eye Disease; dry eye; trehalose; artificial tears