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

NCT ID: NCT00721656

Last Updated: 2009-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

KLS-0611

Group Type EXPERIMENTAL

KLS-0611

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

KLS-0611

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Yasuhiro Omori

Role: STUDY_DIRECTOR

Kissei Pharmaceutical Co., Ltd.

Locations

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Japan

Hokkaido Region, , Japan

Site Status

Japan

Kansai Region, , Japan

Site Status

Japan

Kanto Region, , Japan

Site Status

Japan

Kyushu Region, , Japan

Site Status

Japan

Shikoku Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KLS1201

Identifier Type: -

Identifier Source: org_study_id

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