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A Study for Evaluation of the Efficacy and Safety of SI-614 Ophthalmic Solution in Patient With Dry Eye (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 5 years
Awards & highlights
Pivotal Trial
Summary
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.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
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
8,727 Total Patients Enrolled
Seikagaku CorporationLead Sponsor
13 Previous Clinical Trials
4,280 Total Patients Enrolled
George OuslerStudy DirectorORA, Inc.