Actively Recruiting
The Effects of 3% Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function
Led by Southern California College of Optometry at Marshall B. Ketchum University · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Effects of 3% Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects over 18 years old with moderate-to-severe dry eye, meeting dry eye stages 3 or 4 criteria
- Normal eyelid position and closure
- For aqueous tear deficiency, Schirmer I test less than 5.0 mm wetting in 5 minutes without anesthesia
You will not qualify if you...
- Eye surgery in either eye within the past 12 months (except LASIK or kerato-refractive surgery if over 12 months ago)
- Serious eye trauma in either eye within the past 6 months
- Hypersensitivity to any study medication components
- History of certain eye infections or diseases (herpes simplex keratitis, vaccinia, varicella, viral, bacterial, mycobacterial, fungal eye diseases)
- Active ocular allergy
- Pregnant, nursing, or planning pregnancy females
- Eyelid deformities worse than mild (ectropion, entropion, ptosis)
- Use of topical ocular medications during the study
- Unstable use of systemic steroids, immunosuppressives, or anticholinergic drugs for autoimmune connective tissue disease within 30 days prior
- Uncontrolled diabetes or peripheral neuropathy
- Active intraocular inflammation like iritis
- Wearing rigid gas permeable or scleral contact lenses within 6 months; soft lenses not worn within 1 month prior
- Use of punctual plugs within 30 days before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Marshall B. Ketchum University
Fullerton, California, United States, 92831
Actively Recruiting
Research Team
S
Shora Ansari, OD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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