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ST-100-002 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

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

Trial Design

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)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

ORA, Inc.Lead Sponsor

69 Previous Clinical Trials

8,777 Total Patients Enrolled

Stuart Therapeutics, Inc.Industry Sponsor

1 Previous Clinical Trials

160 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals enrolled in this clinical trial?

"Indeed, the details available on clinicaltrials.gov confirm that this study is currently in search of eligible participants. The trial was initially posted on December 29th, 2023 and underwent its most recent update on January 16th, 2024. A total of 175 individuals will be enrolled at a single designated site for this clinical investigation."

Answered by AI

Is the enrollment for this clinical trial currently open?

"Indeed, clinicaltrials.gov verifies that this trial is actively seeking eligible individuals. The study was originally posted on December 29th, 2023 and most recently updated on January 16th, 2024. A total of 175 participants will be enrolled across a single site."

Answered by AI

Has the FDA given its approval to ST-100-002?

"Based on our evaluation at Power, the safety of ST-100-002 is rated as 3. This rating aligns with it being a Phase 3 trial, indicating that there exists evidence supporting its efficacy and multiple rounds of data confirming its safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)

2023. "Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06178679.

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