Recruiting

Trehalose

Sponsor:

Southern California College of Optometry at Marshall B. Ketchum University

Code:

NCT06655441

Conditions

Dry Eye Disease (DED)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3% trehalose

Study Details

Brief summary:

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

Dry Eye Disease (DED)

Study ID

NCT06655441

Start date

Mar 1, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

3% trehalose

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Shora Ansari, OD, MS

714-463-7536sansari@ketchum.edu

Locations

Marshall B. Ketchum University

Recruiting

Fullerton, California, United States, 92831

Contacts

Shora Ansari, OD, MS

714-463-7536sansari@ketchum.edu

Principal Investigator:

Shora Ansari, OD, MS

More Information

Sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • dry eye
  • trehalose
  • artificial tears

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Southern California College of Optometry at Marshall B. Ketchum University on 2026-05-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.