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

May 10, 2023 updated by: Seikagaku Corporation
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States
        • SKK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Drug: Vehicle
1 drop in each eye 4 times a day
Experimental: High concentration SI-614
Drug: High concentration SI-614
1 drop in each eye 4 times a day
Experimental: Low concentration SI-614
Drug: Low concentration SI-614
1 drop in each eye 4 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in TFBUT
Time Frame: Day 27
Day 27
Mean change from baseline in symptom score
Time Frame: Day 21 - 27
Day 21 - 27

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seikagaku Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

March 18, 2012

First Submitted That Met QC Criteria

March 18, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 614/1121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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