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Clinical Trials/NCT02205840
NCT02205840
Completed
Phase 2

A Multicenter, Randomized, Double-masked and Placebo-controlled Study Evaluating the Efficacy and Safety of SI-614 Ophthalmic Solution in Patients With Dry Eye

Seikagaku Corporation0 sites240 target enrollmentJuly 2014
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ConditionsDry Eye Syndromes
InterventionsVehicleSI-614
DrugsSI-614Vehicle

Overview

Phase
Phase 2
Intervention
Vehicle
Conditions
Dry Eye Syndromes
Sponsor
Seikagaku Corporation
Enrollment
240
Primary Endpoint
Corneal staining score
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar 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
July 2014
End Date
November 2014
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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 an uncontrolled psychiatric condition, or substance or alcohol abuse
  • •Women who is pregnant, nursing or planning a pregnancy

Arms & Interventions

Placebo Vehicle

Intervention: Vehicle

SI-614

Intervention: SI-614

Outcomes

Primary Outcomes

Corneal staining score

Time Frame: Up to 28 days

Symptom score

Time Frame: Up to 28 days

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