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OpenTrials
Completed

NCT Number: NCT01558999

A Clinical Study Evaluating the Safety and Efficacy 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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SKK Investigational Site

Andover, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High concentration SI-614

Drug

1 drop in each eye 4 times a day

Low concentration SI-614

Drug

1 drop in each eye 4 times a day

Vehicle

Drug

1 drop in each eye 4 times a day

Primary outcomes

  1. Mean change from baseline in TFBUT

    Time frame: Day 27

  2. Mean change from baseline in symptom score

    Time frame: Day 21 - 27

Sponsors and collaborators

Lead sponsor

Seikagaku Corporation

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
First posted
Mar 20, 2012
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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