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NCT01558999 Clinical Trial

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

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01558999
Other study ID # 614/1121
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2012

Study information
Verified date May 2023
Source Seikagaku Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• High concentration SI-614
1 drop in each eye 4 times a day
• Low concentration SI-614
1 drop in each eye 4 times a day
• Vehicle
1 drop in each eye 4 times a day

Locations
Country Name City State
United States SKK Investigational Site Andover Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Seikagaku Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change from baseline in TFBUT Day 27
Primary Mean change from baseline in symptom score Day 21 - 27
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