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Trehalose Solution for Dry Eye Syndrome

Phase 4
Waitlist Available
Research Sponsored by Southern California College of Optometry at Marshall B. Ketchum University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have normal eyelid position and closure
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
Must not have
Use of concomitant topical ocular medications during the study duration
Individuals with uncontrolled diabetes or history or evidence of peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of treatment at 4 weeks
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

"This trial aims to study how trehalose, a component in artificial tears, affects the protective function of the cornea. Researchers will look at how trehalose impacts corneal dryness and

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, typical reactions to ophthalmic solutions may include temporary discomfort, redness in the eyes, blurred vision, or a feeling that something is in your eye.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eyelids open, close, and are positioned normally.
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I am over 18 and have moderate-to-severe dry eye condition.
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My dry eye test showed less than 5 mm wetting in 5 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am using eye drops or other eye medications during the study.
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I have diabetes that is not well-managed or I have nerve damage.
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I have not had a serious eye injury in the last 6 months.
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I have had infections in my eye like herpes, chickenpox, or fungal infections.
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I have a noticeable eyelid deformity.
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I am not pregnant, nursing, or planning to become pregnant during the study.
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I have an active eye inflammation condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of treatment at 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of treatment at 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
corneal epithelial permeability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: OS eye receives 3% trehalose drops and OD eye receives control dropsExperimental Treatment1 Intervention
Group II: OD eyes receives 3% trehalose drops and OS eye receives control dropsExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Southern California College of Optometry at Marshall B. Ketchum UniversityLead Sponsor
23 Previous Clinical Trials
1,427 Total Patients Enrolled
~20 spots leftby Apr 2025
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