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

Part of paid clinical trials in Fullerton, California.

Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Study ID
NCT06655441
Phase
PHASE4
Status
Recruiting

Conditions

  • Dry Eye Disease (DED)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OS eye receives 3% trehalose drops and OD eye receives control drops
  • Other: OD eyes receives 3% trehalose drops and OS eye receives control drops

Primary Outcome Measure

corneal epithelial permeability [ Time Frame: from enrollment to end of treatment at 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Marshall B. Ketchum UniversityFullertonCalifornia92831
Shora Ansari, OD, MS
714-463-7536
Shora Ansari, OD, MS (PRINCIPAL_INVESTIGATOR)

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