Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

To evaluate the efficacy and safety of KLS-0611 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

Japan, Hokkaido Region

Who can participate

Healthy volunteers accepted: No

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

Placebo

Drug

KLS-0611

Drug

Primary outcomes

Corneal-conjunctival staining

Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Important dates

First posted: Jul 24, 2008
Registry last updated: Mar 18, 2009

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