Dry Eye Disease (DED)Phase 4NCT06655441
The Effects of 3% Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function
A Phase 4 study testing 3% trehalose in people with Dry Eye Disease (DED), run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- 3% trehalose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Marshall B. Ketchum University
Fullerton, California, 92831
Shora Ansari, OD, MS, 714-463-7536, sansari@ketchum.edu
Shora Ansari, OD, MS
About this study
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.
Read the detailed description
The aim of this study is to recruit moderate to severe dry eye subjects, enroll them in a randomized contralateral eye-controlled trial with an ophthalmic solution containing trehalose 3% in sterile borate buffered saline in one eye and sterile buffered saline in the contralateral eye. The investigators will accomplish this by enrolling a clinic-based sample, undertaking a standardized examination involving signs and symptoms of dry eye, fluorometry, as well as clinical tear and ocular surface measures at baseline and at one-month post-treatment.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- 3% trehalose
- Keywords
- dry eye, trehalose, artificial tears
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% trehaloseDrug
ophthalmic solution with 3% trehalose in sterile saline in multi dose preservative free bottles
| Study group | Role | What they receive |
|---|---|---|
| OS eye receives 3% trehalose drops and OD eye receives control drops | Experimental | Not described Receives: Drug: 3% trehalose |
| OD eyes receives 3% trehalose drops and OS eye receives control drops | Other | Not described Receives: Drug: 3% trehalose |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal epithelial permeability
The investigators will 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.
Measured: from enrollment to end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized contralateral eye-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shora Ansari, Southern California College of Optometry at Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655441
- Sponsor's protocol ID
- SCCO-Trehalose
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 3% Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function
- ClinicalTrials.gov ID
- NCT06655441
- Acronym / sponsor ID
- SCCO-Trehalose
- Conditions
- Dry Eye Disease (DED)
- Keywords
- dry eye, trehalose, artificial tears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to recruit moderate to severe dry eye subjects, enroll them in a randomized contralateral eye-controlled trial with an ophthalmic solution containing trehalose 3% in sterile borate buffered saline in one eye and sterile buffered saline in the contralateral eye. The investigators will accomplish this by enrolling a clinic-based sample, undertaking a standardized examination involving signs and symptoms of dry eye, fluorometry, as well as clinical tear and ocular surface measures at baseline and at one-month post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized contralateral eye-controlled trial
| Arm | Type | Receives |
|---|---|---|
| OS eye receives 3% trehalose drops and OD eye receives control drops | Experimental | Drug: 3% trehalose |
| OD eyes receives 3% trehalose drops and OS eye receives control drops | Other | Drug: 3% trehalose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3% trehaloseophthalmic solution with 3% trehalose in sterile saline in multi dose preservative free bottles | Drug | OD eyes receives 3% trehalose drops and OS eye receives control drops, OS eye receives 3% trehalose drops and OD eye receives control drops |
Primary outcome
corneal epithelial permeability
Time frame: from enrollment to end of treatment at 4 weeks
The investigators will 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3% trehalose in people with Dry Eye Disease (DED), run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shora Ansari, OD, MS (714-463-7536, sansari@ketchum.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal epithelial permeability (time frame: from enrollment to end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.