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

NCT06655441 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-05

No results posted yet for this study

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)

Interventions

DRUG

3% trehalose

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06655441 on ClinicalTrials.gov