A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye

Seikagaku Corporation1 site in 1 country150 target enrollmentMarch 2012

ConditionsDry Eye Syndromes

InterventionsHigh concentration SI-614 Low concentration SI-614 Vehicle

DrugsHigh concentration SI-614 Low concentration SI-614 Vehicle

Overview

Phase: Phase 2
Intervention: High concentration SI-614
Conditions: Dry Eye Syndromes
Sponsor: Seikagaku Corporation
Enrollment: 150
Locations: 1
Primary Endpoint: Mean change from baseline in symptom score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

July 2012

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seikagaku Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be at least 18 years of age
•Have provided written informed consent
•Have dry eye in both eyes

Exclusion Criteria

•Use of contact lenses
•Have an uncontrolled systemic disease
•Have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse
•Women who is pregnant, nursing or planning a pregnancy