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

July 10, 2023 updated by: Seikagaku Corporation

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

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)

240

Phase

  • Phase 2
  • Phase 3

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

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 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
Experimental: SI-614
Drug: SI-614
1 drop in each eye
Placebo Comparator: Placebo Vehicle
Drug: Vehicle
1 drop in each eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal staining score
Time Frame: Up to 28 days
Up to 28 days
Symptom score
Time Frame: Up to 28 days
Up to 28 days

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

July 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimated)

July 31, 2014

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 614/1131

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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