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: Low concentration SI-614; Drug: Vehicle; Drug: High concentration SI-614

• Registration Number: NCT01558999
• 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: 2012-03
• Study First Submitted: 2012-03-18
• Study First Submitted QC: 2012-03-18
• Study First Posted: 2012-03-20
• Primary Completion: 2012-07
• Disposition First Submitted: 2013-08-30
• Disposition First Submitted QC: 2013-08-30
• Disposition First Posted: 2013-09-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low concentration SI-614	Low concentration SI-614	-
Vehicle	Vehicle	-
High concentration SI-614	High concentration SI-614	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in symptom score	Day 21 - 27
Mean change from baseline in TFBUT	Day 27

Trial Locations

Locations (1)

SKK Investigational Site; 🇺🇸 Andover, Massachusetts, United States