Trehalose Solution for Dry Eye Syndrome

Overseen By Shora Ansari, OD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

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

Must not be taking: Systemic steroids, Immunosuppressive agents

Disqualifiers: Ocular surgery, Serious trauma, Herpes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

30 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial requires that you do not use any other eye medications during the study. If you are taking systemic steroids, immunosuppressive agents, or anti-cholinergic medications, you must have been on a stable dose for at least 30 days before joining the trial.

What data supports the effectiveness of the drug 3% Trehalose Ophthalmic Solution for treating dry eye syndrome?

Research shows that trehalose-based eye drops improve symptoms of dry eye syndrome by increasing tear stability and reducing eye dryness. Studies found that patients using trehalose treatments had better results in various measures of eye health compared to those using other treatments, with no reported adverse effects. ^{1 2 3 4 5}

Is trehalose solution safe for treating dry eye syndrome?

Research shows that trehalose eye drops are safe for treating dry eye syndrome, with no reported adverse events in studies. ^{1 2 4 6 7}

How is the trehalose solution different from other dry eye treatments?

The 3% Trehalose Ophthalmic Solution is unique because it protects corneal cells from drying out and enhances tear film stability, which can improve both the physical condition of the eye and the sensation of dryness. This solution is particularly effective when combined with hyaluronic acid, offering significant improvements in tear stability and reducing dry eye symptoms compared to other treatments like carmellose sodium. ^{1 3 4 5 7}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3% trehalose ophthalmic solution in one eye and control drops in the other eye

4 weeks

Baseline and 1-month post-treatment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 3% Trehalose Ophthalmic Solution

Trial Overview 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.

Participant Groups

Group I: OS eye receives 3% trehalose drops and OD eye receives control drops Experimental Treatment 1 Intervention

Group II: OD eyes receives 3% trehalose drops and OS eye receives control drops Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Southern California College of Optometry at Marshall B. Ketchum University

Lead Sponsor

Trials

24

Recruited

1,400+

References

1. India pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of trehalose: An efficient autophagic bioprotectant in the management of dry eye disease. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Trehalose and Dry Eye Disease: A Comprehensive Systematic Review of Randomized Controlled Trials. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of efficacy of trehalose-based eye drops versus topical 0.1% Hyaluronic Acid for management of clinically significant dry eye using non-invasive investigational modalities. [2022]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The effects of a trehalose-based drug used after laser keratorefractive surgeries]. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Tear Film Stabilization and Symptom Improvement in Dry Eye Disease: The Role of Hyaluronic Acid and Trehalose Eyedrops versus Carmellose Sodium. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

Trehalose versus hyaluronan or cellulose in eyedrops for the treatment of dry eye. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Trehalose eye drops in the treatment of dry eye syndrome. [2022]