A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye

(SIDE Trial)

Recruiting at 6 trial locations

Overseen By Yujiro Une

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Seikagaku Corporation

Disqualifiers: Blepharitis, Ocular infection, Ocular surgery, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

232 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing an eye drop solution called SI-614 to see if it can help adults with dry eyes by reducing dryness and irritation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research Team

George Ousler

Principal Investigator

ORA, Inc.

Eligibility Criteria

Inclusion Criteria

If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and will be using an adequate method of birth control throughout the study period.

You have experienced dry eyes in both eyes for at least 6 months before the first visit.

You have used or want to use eye drops for dry eyes within the last 6 months before the study.

Exclusion Criteria

Have a condition or is in a situation that, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patients' participation in the study.

You are allergic or sensitive to the study drug or its components.

You have an eye condition like blepharitis, meibomian gland dysfunction, or lid margin inflammation that requires treatment and might affect the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SI-614 ophthalmic solution or placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SI-614
• Vehicle

Participant Groups

Group I: SI-614 Experimental Treatment 1 Intervention

Group II: Vehicle Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Seikagaku Corporation

Lead Sponsor

Trials

14

Recruited

4,500+

Statistics & Data Corporation

Collaborator

Trials

4

Recruited

1,000+

Statistics & Data Corporation

Industry Sponsor

Trials

5

Recruited

1,100+

ORA, Inc.

Industry Sponsor

Trials

72

Recruited

9,200+

Stuart Abelson

ORA, Inc.

Chief Executive Officer since 2007

BSc in Neuroscience from Bates College, MBA from Northwestern University

Dr. Gustavo De Moraes

ORA, Inc.

Chief Medical Officer since 2022

MD, PhD in Ophthalmic Sciences, MPH in Biostatistics