A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome

Kissei Pharmaceutical Co., Ltd.

Overview

The purpose of this study is to investigate the superiority of KCT-0809 to placebo, and to evaluate safety in dry eye patients with Sjögren's syndrome

Study Type

INTERVENTIONAL

Conditions

Dry Eye With Sjögren's Syndrome

Interventions

KCT-0809 ophthalmic solutionDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Dry eye patients with Sjögren's syndrome * Corneal and conjunctival damage Exclusion Criteria: * Severe ophthalmic disorder * Punctal plugs or surgery for occlusion of the lacrimal puncta

Locations (1)

Unnamed facility

Tokyo and Other Japanese City, Japan

Outcomes

Primary Outcomes

Score of the corneal staining

Time frame: 12 weeks

Secondary Outcomes

Score of the conjunctival staining

Time frame: 12 weeks

Data from ClinicalTrials.gov

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