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Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma

NCT ID: NCT00441883

Last Updated: 2020-09-14

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

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-07-31

Brief Summary

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This study will evaluate the safety and efficacy of PF 03187207.

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Detailed Description

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Conditions

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Primary Open Angle Glaucoma Ocular Hypertension Pigmentary Glaucoma Pseudoexfoliative Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-03187207 and Latanoprost Vehicle

One drop of each, once daily in study eye for 28 days

Group Type EXPERIMENTAL

PF-03187207 and Latanoprost Vehicle

Intervention Type DRUG

Latanoprost 0.005% and PF-03187207 Vehicle

One drop of each, once daily in study eye for 28 days

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005% and PF-03187207 Vehicle

Intervention Type DRUG

Interventions

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PF-03187207 and Latanoprost Vehicle

Intervention Type DRUG

Latanoprost 0.005% and PF-03187207 Vehicle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes

Exclusion Criteria

-Closed or barely open anterior chamber angle or a history of acute angle closure in either eye
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NicOx Inc.

INDUSTRY

Sponsor Role collaborator

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Harper

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Pfizer Investigational Site

Artesia, California, United States

Site Status

Pfizer Investigational Site

Newport Beach, California, United States

Site Status

Pfizer Investigational Site

Petaluma, California, United States

Site Status

Pfizer Investigational Site

Poway, California, United States

Site Status

Pfizer Investigational Site

Danbury, Connecticut, United States

Site Status

Pfizer Investigational Site

Jacksonville, Florida, United States

Site Status

Pfizer Investigational Site

Ormond Beach, Florida, United States

Site Status

Pfizer Investigational Site

Atlanta, Georgia, United States

Site Status

Pfizer Investigational Site

Atlanta, Georgia, United States

Site Status

Pfizer Investigational Site

Evansville, Indiana, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Rochester, New York, United States

Site Status

Pfizer Investigational Site

Charlotte, North Carolina, United States

Site Status

Pfizer Investigational Site

High Point, North Carolina, United States

Site Status

Pfizer Investigational Site

Tulsa, Oklahoma, United States

Site Status

Pfizer Investigational Site

Cranberry Township, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9441001&StudyName=A%20Phase%202%2C%20Dose-Finding%20Study%20Comparing%20the%20Safety%20and%20Efficacy%20of%20Latanoprost%20to%20a%20Novel%20Treatment%20for%20Glaucoma

To obtain contact information for a study center near you, click here.

Other Identifiers

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A9441001

Identifier Type: -

Identifier Source: org_study_id

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