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SI-614 for Dry Eye Syndrome (SIDE Trial)

Phase 3

Waitlist Available

Research Sponsored by Seikagaku Corporation

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 84 days

Awards & highlights

SIDE Trial Summary

This trial will compare SI-614, an experimental eye drop, to a placebo to see if it is effective and safe for treating dry eye.

Eligible Conditions

Dry Eye Syndrome

SIDE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 84 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

Change from baseline to Day 29 in fluorescein staining score

Secondary outcome measures

Change from baseline to Day 14 in ocular symptom score

Other outcome measures

Adverse Events

Best-corrected Visual Acuity

Slit-lamp Biomicroscopy

SIDE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SI-614Experimental Treatment1 Intervention

Group II: VehiclePlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SI-614

2022

Completed Phase 3

~480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Statistics & Data CorporationUNKNOWN

4 Previous Clinical Trials

825 Total Patients Enrolled

ORA, Inc.Industry Sponsor

69 Previous Clinical Trials

8,804 Total Patients Enrolled

Seikagaku CorporationLead Sponsor

13 Previous Clinical Trials

4,280 Total Patients Enrolled

Frequently Asked Questions

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

How many people have signed up to participate in this clinical trial?

"To carry out this clinical trial, the research team needs to recruit 230 patients that fit the specific inclusion criteria. The sponsor organization, ORA Inc., will oversee different locations including Eye Research Foundation in Newport Beach, California and Butchertown Clinical Trials in Louisville, Kentucky."

Answered by AI

Are patients being actively recruited for this trial at this time?

"This medical study, which was first posted on July 28th 2022, is actively recruiting patients."

Answered by AI

In how many different places is this trial being run today?

"Currently, there are 5 sites enrolling patients for this clinical trial. The locations of these recruitment centres are Newport Beach, Louisville and Shelby as well as 2 other undisclosed locations. If you decide to participate in this study, please choose the site closest to reduce travel burden."

Answered by AI

Could you explain the dangers that SI-614 poses to patients?

"SI-614 has been given a safety rating of 3 by our team at Power. This is because it is a Phase 3 trial, meaning that there is some data to support its efficacy as well as multiple rounds of data supporting its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05411367.