A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome

Completed

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Key information

Conditions

Dry Eye With Sjögren's Syndrome Conjunctival Diseases Corneal Diseases Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo and Other Japanese City, Japan

Who can participate

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

Inclusion criteria

Dry eye patients with Sjögren's syndrome
Corneal and conjunctival damage

Exclusion criteria

Severe ophthalmic disorder
Punctal plugs or surgery for occlusion of the lacrimal puncta

Treatment and study plan

KCT-0809 ophthalmic solution

Drug

Placebo

Drug

Primary outcomes

Score of the corneal staining

Time frame: 12 weeks

Secondary outcomes

Score of the conjunctival staining

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Primary completion: 2017
First posted: Jul 20, 2015
Registry last updated: May 17, 2017

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