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

NCT06655441 | Recruiting Phase 4 FDA Drug

• 1 other identifier: SCCO-Trehalose
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease (DED)

Keywords

dry eye; trehalose; artificial tears

Outcome Measures

Primary Outcomes (1)

• corneal epithelial permeability

  The investigators will 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.

  from enrollment to end of treatment at 4 weeks

Study Arms (2)

OS eye receives 3% trehalose drops and OD eye receives control drops

EXPERIMENTAL

Drug: 3% trehalose

OD eyes receives 3% trehalose drops and OS eye receives control drops

OTHER

Drug: 3% trehalose

Interventions

3% trehalose DRUG

ophthalmic solution with 3% trehalose in sterile saline in multi dose preservative free bottles

OD eyes receives 3% trehalose drops and OS eye receives control drops; OS eye receives 3% trehalose drops and OD eye receives control drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University: lead

Study Sites (1)

Marshall B. Ketchum University

Fullerton, California, 92831, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Trehalose

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Central Study Contacts

Shora Ansari, OD, MS

CONTACT

714-463-7536; sansari@ketchum.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized contralateral eye-controlled trial

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 23, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)