ST-100 for Dry Eye Syndrome

Phase 3

Recruiting

Research Sponsored by ORA, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be at least 18 years of age;

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 49 days

Awards & highlights

Pivotal Trial

Summary

This trial is studying the safety and effectiveness of a medication called ST-100 for people diagnosed with dry eye disease. The medication is an eye solution and the trial will compare it to a control solution to

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While not specified here, side effects may include typical reactions related to ophthalmic solutions such as temporary vision changes, discomfort or irritation in the eyes, redness, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 49 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~49 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 49 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle using Schirmer's test at day 29

Secondary study objectives

Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution

Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle for the treatment of the signs and symptoms of DED

Other study objectives

Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle using additional measures