Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Placebo; Drug: KLS-0611

• Registration Number: NCT00721656
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

To evaluate the efficacy and safety of KLS-0611 compared to placebo in patients with dry eye syndromes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-24
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-16
• Last Update Posted: 2009-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
KLS-0611	KLS-0611	-

Primary Outcome Measures

Name	Time	Method
Corneal-conjunctival staining	4 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Shikoku region, Japan