Trehalose Solution for Dry Eye Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Dry Eye Syndrome, a condition where the eyes do not produce enough tears or the right quality of tears. Participants should be experiencing corneal dryness and are willing to use eye drops containing trehalose for one month.

Inclusion Criteria

My eyelids open, close, and are positioned normally.

I am over 18 and have moderate-to-severe dry eye condition.

My dry eye test showed less than 5 mm wetting in 5 minutes.

Exclusion Criteria

History of hypersensitivity to any component of the study medications

History or evidence of active ocular allergy

Individuals using punctual plugs inserted within 30 days of study start

+10 more

Participant Groups

The study is testing the effectiveness of eye drops with 3% trehalose on improving corneal barrier function. This involves seeing if these eye drops can help prevent dye from penetrating into the eye, which would indicate better protection against dryness.

2Treatment groups

Experimental Treatment

Group I: OS eye receives 3% trehalose drops and OD eye receives control dropsExperimental Treatment1 Intervention

Group II: OD eyes receives 3% trehalose drops and OS eye receives control dropsExperimental Treatment1 Intervention