ST-100 for Dry Eye Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: ORA, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A Phase 3 Multi-Center, Randomized, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed with Dry Eye Disease (DED)

Eligibility Criteria

This trial is for adults over 18 with Dry Eye Disease (DED) who have used or wanted to use eye drops for DED in the last 6 months. Participants should have a history of DED for at least 6 months, experience certain levels of eye discomfort and dryness, and meet specific criteria on eye tests.

Inclusion Criteria

You have a certain score from an eye test using a special dye, called corneal fluorescein staining, that shows potential eye issues.

I have used or wanted to use eye drops for dry eyes in the last 6 months.

I am 18 years old or older.

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Treatment Details

Interventions

ST-100 (vezocolmitide) (Other)
Vehicle (Other)

Trial OverviewThe study is testing ST-100 (vezocolmitide) Ophthalmic Solution against a placebo solution (vehicle). It's a phase 3 trial where participants are randomly assigned to either receive the test medication or placebo without knowing which one they're getting.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ST-100-002Experimental Treatment1 Intervention

ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Bilaterally twice daily for 7 weeks (49 days)

Group II: Vehicle Ophthalmic SolutionPlacebo Group1 Intervention

Vehicle Ophthalmic Solution Bilaterally twice daily for 7 weeks (49 days)