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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eye drops containing 3% trehalose to determine if they can enhance the eye's natural barrier, potentially keeping out irritants more effectively. It targets individuals with moderate-to-severe dry eye who frequently experience eye discomfort. Participants must have normal eyelid function and no recent eye surgeries or serious eye conditions. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

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 is the safety track record for the 3% Trehalose Ophthalmic Solution?

Earlier studies have shown that trehalose eye drops are safe for treating dry eye syndrome. Research indicates that these drops do not cause unexpected or harmful side effects. Trehalose is already present in some over-the-counter artificial tears, suggesting it is generally well-tolerated. Overall, the safety profile of trehalose eye drops appears favorable, making them a reliable option for those considering participation in a trial for dry eye treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the 3% Trehalose Ophthalmic Solution for dry eye syndrome because it introduces a novel approach compared to existing treatments like artificial tears, anti-inflammatory drops, and punctal plugs. Unlike these standard treatments, the trehalose solution harnesses the unique properties of trehalose, a sugar known for its cell-protective and moisture-retaining qualities, to potentially offer better protection and hydration to the eye surface. This innovative mechanism targets the underlying cellular stress and damage associated with dry eye, which could lead to improved, longer-lasting relief.

What evidence suggests that 3% trehalose ophthalmic solution might be an effective treatment for dry eye syndrome?

Research has shown that trehalose eye drops effectively treat dry eye syndrome. Studies have found that these drops can greatly improve symptoms like dryness and discomfort in people with moderate to severe dry eyes. In this trial, one eye of each participant will receive 3% trehalose drops, while the other eye will receive control drops. One study found that women of different ages experienced noticeable relief from symptoms after using trehalose eye drops. Another study demonstrated that using these drops for a month improved eye health and reduced damage. Overall, trehalose is considered a safe and effective ingredient in artificial tears for managing dry eye conditions. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10707449/

Trehalose and Dry Eye Disease: A Comprehensive ... No adverse events after trehalose tear-substitute treatments were reported. Trehalose tear substitutes are a safe and effective treatment for DED. Therefore, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642002012198

Trehalose eye drops in the treatment of dry eye syndrome Conclusions. Trehalose solution was an effective and safe eyedrop for the treatment of moderate to severe dry eye syndrome in this group of patients.

3. contactlensjournal.com contactlensjournal.com/article/S1367-0484(23)00049-8/fulltext

Efficacy of artificial tears containing trehalose and ... Artificial tears with trehalose and HA significantly improved the symptoms of DED in women aged 42–54 and ≥ 55 years. The decrease in symptoms ...

4. journals.sagepub.com journals.sagepub.com/doi/10.5301/ejo.5000836

A Randomized, Controlled Study of the Efficacy and Safety ... The primary efficacy criterion was met, with HA-trehalose improving keratoconjunctivitis sicca (Oxford score) after 1 month (day 35) and being noninferior to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6056167/

Trehalose/hyaluronate eyedrop effects on ocular surface ... A decrease in ocular discomfort symptoms, surface damage, and tear cytokine levels was shown after 2 months' treatment with trehalose/hyaluronate tear ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06655441?cond=%22Lacrimal%20Apparatus%20Diseases%22&aggFilters=status:not%20rec&rank=3

Study Details | The Effects of 3% Trehalose Ophthalmic ... The purpose of this research study is to evaluate the effects of trehalose, an ingredient found in commercially available artificial tears, on the corneal ...

7. mdpi.com mdpi.com/2218-273X/10/5/809

Trehalose for Ocular Surface Health This review discusses the scientific findings on potential functions of trehalose in oxidative stress, protein clearance, and inflammation

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT03830359/Prot_000.pdf

Efficacy and Safety Assessment of T2769 in patients with ... Both sodium hyaluronate 0.15% and trehalose 3% eye drops are currently marketed by. Laboratoires THEA as preservative-free ophthalmic ...