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

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: SI-614; Drug: Vehicle

• Registration Number: NCT02205840
• Lead Sponsor: Seikagaku Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2014-11
• Disposition First Submitted: 2015-01-19
• Disposition First Submitted QC: 2015-01-19
• Disposition First Posted: 2015-01-29
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SI-614	SI-614	-
Placebo Vehicle	Vehicle	-

Primary Outcome Measures

Name	Time	Method
Corneal staining score	Up to 28 days
Symptom score	Up to 28 days