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

Primary Purpose

Dry Eye Syndromes

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Placebo

KLS-0611

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry eye syndromes, Corneal diseases, Conjunctival Diseases

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Japan
Japan
Japan
Japan
Japan

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

KLS-0611

Arm Description

Outcomes

Primary Outcome Measures

Corneal-conjunctival staining

Secondary Outcome Measures

Full Information

NCT ID

NCT00721656

First Posted

July 22, 2008

Last Updated

March 16, 2009

Sponsor

Kissei Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00721656

Brief Title

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

Official Title

A Randomized, Double Blind, Placebo Controlled, Phase 2 Study of KLS-0611 in Patients With Dry Eye Syndromes

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Kissei Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes

Keywords

Dry eye syndromes, Corneal diseases, Conjunctival Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

KLS-0611

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

KLS-0611

Primary Outcome Measure Information:

Title

Corneal-conjunctival staining

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasuhiro Omori

Organizational Affiliation

Kissei Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Japan

City

Hokkaido region

Country

Japan

Facility Name

Japan

City

Kansai region

Country

Japan

Facility Name

Japan

City

Kanto region

Country

Japan

Facility Name

Japan

City

Kyushu region

Country

Japan

Facility Name

Japan

City

Shikoku region

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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