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NCT01427816 Clinical Trial

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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01427816
Other study ID # KCT1202
Secondary ID
Status Completed
Phase Phase 2
First received September 1, 2011
Last updated October 29, 2013

Study information
Verified date October 2013
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

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

Recruitment information / eligibility
Status Completed
Enrollment 180
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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• KCT-0809

• 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 Corneal staining score 6 weeks No
Secondary Conjunctival staining score 6 weeks No
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