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OpenTrials
Completed

NCT Number: NCT01427816

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

To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndrome.

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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

Tokyo and Other Japanese City, Japan

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

KCT-0809

Drug

Placebo

Drug

Primary outcomes

  1. Corneal staining score

    Time frame: 6 weeks

Secondary outcomes

  1. Conjunctival staining score

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome

Important dates

First posted
Sep 2, 2011
Registry last updated
Oct 30, 2013

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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