A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329

NCT ID: NCT00934089

Last Updated: 2021-05-03

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

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This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.

Detailed Description

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Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PF-04217329 + placebo

Active study drug + latanoprost vehicle

Group Type EXPERIMENTAL

PF-04217329

Intervention Type DRUG

Topical ocular solution, once-daily for 14 days

latanoprost vehicle

Intervention Type DRUG

Topical ocular solution, once-daily for 14 days

PF-04217329 + latanoprost

Active study drug + latanoprost

Group Type EXPERIMENTAL

PF-04217329

Intervention Type DRUG

Topical ocular solution, once-daily for 14 days

latanoprost

Intervention Type DRUG

Topical ocular solution, once-daily for 14 days

Interventions

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PF-04217329

Topical ocular solution, once-daily for 14 days

Intervention Type DRUG

latanoprost vehicle

Topical ocular solution, once-daily for 14 days

Intervention Type DRUG

PF-04217329

Topical ocular solution, once-daily for 14 days

Intervention Type DRUG

latanoprost

Topical ocular solution, once-daily for 14 days

Intervention Type DRUG

Other Intervention Names

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Xalatan

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes
* Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye at 8 AM after discontinuing previous glaucoma treatment
* Visual acuity correctable to 20/100 or better in each eye.

Exclusion Criteria

* Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
* Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.
* Advanced glaucoma or a history of severe central visual field loss in either eye.
* History of ocular surgery or trauma in either eye within 6 months of the screening visit.
* History of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 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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West Coast Clinical Trials, LLC

Cypress, California, United States

Site Status

Glory Medical Group

Garden Grove, California, United States

Site Status

East-West Eye Institute

Gardena, California, United States

Site Status

Ophthalmology Corporation

Long Beach, California, United States

Site Status

East-West Eye Institute

Los Angeles, California, United States

Site Status

Los Angeles Eye Medical Group

Los Angeles, California, United States

Site Status

Eye Research Foundation

Newport Beach, California, United States

Site Status

Southern California Glaucoma Consultants

Pasadena, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A0191002

Identifier Type: -

Identifier Source: org_study_id

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