NCT06655441 · Southern California College of Optometry at Marshall B. Ketchum University
The Effects of 3% Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult subjects, \> age 18 years, with moderate-to-severe dry eye, defined as fitting criteria for dry eye stages 3 or 4 of the MGD Workshop Management and Treatment subcommittee report.
- Subjects must have normal eyelid position and closure.
- For enrollment as aqueous tear deficiency, subjects must have a Schirmer I result of \< 5.0 mm wetting in 5 minutes without anesthesia.
Exclusion criteria
- History or evidence of ocular or intraocular surgery in either eye within the past twelve months. LASIK and other kerato-refractive procedure patients can qualify if the most recent surgery or enhancement was 12 or more months prior.
- History or evidence of serious ocular trauma in either eye within the past six months.
- History of hypersensitivity to any component of the study medications.
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye.
- History or evidence of active ocular allergy.
- Females who are pregnant, nursing, or planning a pregnancy during the study.
- Evidence of greater than mild eyelid deformity (e.g., ectropion, entropion, ptosis).
- Use of concomitant topical ocular medications during the study duration.
- Individuals using systemic steroids, immunosuppressive agents and/or anti-cholinergic (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in the study if they have not been on a stable dosing regimen for a minimum of 30 days prior to the visit.
- Individuals with uncontrolled diabetes or history or evidence of peripheral neuropathy.
- Active intraocular inflammatory conditions such as iritis.
- Individuals wearing rigid gas permeable or scleral contact lenses within the previous six months of enrollment. Subjects can have worn soft lenses, but not within one month prior to enrollment.
- Individuals using punctual plugs inserted within 30 days of study start.
Where
- Fullerton, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations