A Late Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes

The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.

Completed

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Key information

Conditions

Dry Eye Syndromes Conjunctival Diseases Corneal Diseases Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo and Other Japanese City, Japan

Who can participate

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

Inclusion criteria

Corneal and conjunctival damage
Insufficiency of lacrimal secretion
Ocular symptom

Exclusion criteria

Severe ophthalmic disorder
Punctual 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 conjunctival staining

Time frame: 8weeks

Secondary outcomes

Incidences of Adverse Events

Time frame: 8weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Primary completion: 2014
First posted: Jul 2, 2013
Registry last updated: Oct 19, 2015

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