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OS eye receives 3% trehalose drops and OD eye receives control drops 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
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of treatment at 4 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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 prevent penetration of sodium fluorescein dye into the eye) after using eye drops that contain 3% trehalose for one month.

Eligible Conditions
  • Dry Eye Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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

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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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