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

Phase 3

Completed

• Conditions: Dry Eye With Sjögren's Syndrome
• Interventions: Drug: Placebo; Drug: KCT-0809 ophthalmic solution

• Registration Number: NCT02503189
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Primary Completion: 2017-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
KCT-0809	KCT-0809 ophthalmic solution	-

Primary Outcome Measures

Name	Time	Method
Score of the corneal staining	12 weeks

Secondary Outcome Measures

Name	Time	Method
Score of the conjunctival staining	12 weeks