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
NCT number | NCT01692145 |
Other study ID # | KCT1204 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | September 20, 2012 |
Last updated | May 29, 2014 |
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 |
The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.
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 |
Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Japan | Tokyo and Other Japanese City |
Lead Sponsor | Collaborator |
---|---|
Kissei Pharmaceutical Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score of the Corneal conjunctival staining | No |
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