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.

Completed

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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 / Phase 3

Primary location

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 an uncontrolled psychiatric condition, or substance or alcohol abuse
Women who is pregnant, nursing or planning a pregnancy

Treatment and study plan

SI-614

Drug

1 drop in each eye

Vehicle

Drug

1 drop in each eye

Primary outcomes

Corneal staining score

Time frame: Up to 28 days
Symptom score

Time frame: Up to 28 days

Sponsors and collaborators

Lead sponsor

Seikagaku Corporation

Industry

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2014
First posted: Jul 31, 2014
Registry last updated: Jul 12, 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.

Published trials that share one or more normalized conditions with this study.

Completed