A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease

NCT ID: NCT01135511

Last Updated: 2013-05-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.

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

DOUBLE

Participants Investigators

Study Groups

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Treatment 1

Group Type EXPERIMENTAL

CP-690,550 Eye drops

Intervention Type DRUG

Ophthalmic topical solution, low dose, dosed once/day, 8 weeks

Treatment 2

Group Type EXPERIMENTAL

CP-690,550 Eye drops

Intervention Type DRUG

Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks

Treatment 3

Group Type EXPERIMENTAL

CP-690,550 Eye drops

Intervention Type DRUG

Ophthalmic topical solution, high dose, dosed once/day, 8 weeks

Treatment 4

Group Type PLACEBO_COMPARATOR

CP-690,550 Eye drops-vehicle

Intervention Type DRUG

Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks

Treatment 5

Group Type ACTIVE_COMPARATOR

Sodium Hyaluronate

Intervention Type DRUG

Ophthalmic topical solution, dosed 6 times/day, 8 weeks

Interventions

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CP-690,550 Eye drops

Ophthalmic topical solution, low dose, dosed once/day, 8 weeks

Intervention Type DRUG

CP-690,550 Eye drops

Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks

Intervention Type DRUG

CP-690,550 Eye drops

Ophthalmic topical solution, high dose, dosed once/day, 8 weeks

Intervention Type DRUG

CP-690,550 Eye drops-vehicle

Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks

Intervention Type DRUG

Sodium Hyaluronate

Ophthalmic topical solution, dosed 6 times/day, 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjective symptoms of dry eye for at least 6 months
* Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)

Exclusion Criteria

* Women who are nursing, pregnant or planning pregnancy during the study
* Participation in other studies within 30 days of screening visit
* Ocular disorders that may confound interpretation of study results
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Ichinomiya, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Narashino, Chiba, Japan

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Pfizer Investigational Site

Urayasu, Chiba, Japan

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Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

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Pfizer Investigational Site

Chiba, Japan, Japan

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Pfizer Investigational Site

Tokyo, Japan, Japan

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Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Yokohama, Kangawa, Japan

Site Status

Pfizer Investigational Site

Kyoto, Kyoto, Japan

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Osaka, Osaka, Japan

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Fuji, Shizuoka, Japan

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Pfizer Investigational Site

Numazu, Shizuoka, Japan

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Pfizer Investigational Site

Shizuoka, Shizuoka, Japan

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Pfizer Investigational Site

Susono, Shizuoka, Japan

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Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

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Pfizer Investigational Site

Hamura, Tokyo, Japan

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Pfizer Investigational Site

Minato-ku, Tokyo, Japan

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Pfizer Investigational Site

Ohta-ku, Tokyo, Japan

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Pfizer Investigational Site

Sumida-ku, Tokyo, Japan

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Pfizer Investigational Site

Tachikawa, Tokyo, Japan

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Pfizer Investigational Site

Taito-ku, Tokyo, Japan

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Tokyo, , Japan

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Pfizer Investigational Site

Gwangju, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Countries

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Japan South Korea

Related Links

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Other Identifiers

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A3921072

Identifier Type: -

Identifier Source: org_study_id

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