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

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: KCT-0809 ophthalmic solution; Drug: Placebo

• Registration Number: NCT01890941
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-07-02
• Primary Completion: 2014-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

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

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KCT-0809 Higher Dose	KCT-0809 ophthalmic solution	-
Placebo	Placebo	-
KCT-0809 Lower Dose	KCT-0809 ophthalmic solution	-

Primary Outcome Measures

Name	Time	Method
Score of the Corneal conjunctival staining	8weeks

Secondary Outcome Measures

Name	Time	Method
Incidences of Adverse Events	8weeks