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NCT01692145 Clinical Trial

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

Dry Eye Syndromes Clinical Trial

Official title:
A Randomized, Double Blind, Placebo Controlled, Parallel Group Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01692145
Other study ID # KCT1204
Secondary ID
Status Completed
Phase Phase 2
First received September 20, 2012
Last updated May 29, 2014

Study information
Verified date May 2014
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• KCT-0809

• Placebo

Locations
Country Name City State
Japan Japan Tokyo and Other Japanese City

Sponsors (1)
Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Score of the Corneal conjunctival staining No
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