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 — DRUGophthalmic 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
- Shora Ansari, OD, MS714-463-7536
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Marshall B. Ketchum University | Fullerton | California | 92831 | Shora Ansari, OD, MS (PRINCIPAL_INVESTIGATOR) |
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