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NCT02205840 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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02205840
Other study ID # 614/1131
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 2014

Study information
Verified date July 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 240
Est. completion date
Est. primary completion date November 2014
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 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:
• SI-614
1 drop in each eye
• Vehicle
1 drop in each eye

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seikagaku Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal staining score Up to 28 days
Primary Symptom score Up to 28 days
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