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

NCT ID: NCT01890941

Last Updated: 2015-10-19

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

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Dry Eye Syndromes

Study Groups

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KCT-0809 Lower Dose

Group Type EXPERIMENTAL

KCT-0809 ophthalmic solution

Intervention Type DRUG

KCT-0809 Higher Dose

Group Type EXPERIMENTAL

KCT-0809 ophthalmic solution

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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KCT-0809 ophthalmic solution

Intervention Type DRUG

Placebo

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

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo and Other Japanese City, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KCT1205

Identifier Type: -

Identifier Source: org_study_id

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