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

Phase 2

Completed

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

• Registration Number: NCT01427816
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Corneal and conjunctival damage
• Insufficiency of lacrimal secretion
• Ocular symptom

Read More

Exclusion Criteria

• Severe ophthalmic disorder
• Punctual plugs or surgery for occlusion of the lacrimal puncta

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KCT-0809 ophthalmic solution, low dose	KCT-0809	-
KCT-0809 ophthalmic solution, high dose	KCT-0809	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Corneal staining score	6 weeks

Secondary Outcome Measures

Name	Time	Method
Conjunctival staining score	6 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Tokyo and Other Japanese City, Japan