A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.

NCT ID: NCT00595101

Last Updated: 2020-09-14

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Open Angle Glaucoma Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-03187207 High Dose and Latanoprost Vehicle

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

Group Type EXPERIMENTAL

PF-03187207

Intervention Type DRUG

Latanoprost Vehicle

Intervention Type DRUG

Latanoprost 0.005% and PF-03187207 Vehicle

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

Group Type EXPERIMENTAL

Latanoprost 0.005%

Intervention Type DRUG

PF-03187207 Vehicle

Intervention Type DRUG

One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.

PF-03187207 Medium Dose and Latanoprost Vehicle

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

Group Type EXPERIMENTAL

PF-03187207

Intervention Type DRUG

Latanoprost Vehicle

Intervention Type DRUG

PF-03187207 Low Dose and Latanoprost Vehicle

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

Group Type EXPERIMENTAL

PF-03187207

Intervention Type DRUG

Latanoprost Vehicle

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-03187207

Intervention Type DRUG

Latanoprost 0.005%

Intervention Type DRUG

PF-03187207 Vehicle

One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.

Intervention Type DRUG

Latanoprost Vehicle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Man or woman at least 20 years of age
* Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.

Exclusion Criteria

* Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
* Contraindications to latanoprost and nitric oxide treatment
* Known latanoprost non-responders
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ken Harper

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Narashino, Chiba, Japan

Site Status

Pfizer Investigational Site

Shimachi, Chiba, Japan

Site Status

Pfizer Investigational Site

Kawasaki, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Kasukabe, Saitama, Japan

Site Status

Pfizer Investigational Site

Fuji, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Mishima, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Susono, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Hachiƍji, Tokyo, Japan

Site Status

Pfizer Investigational Site

Hamura, Tokyo, Japan

Site Status

Pfizer Investigational Site

Minato, Tokyo, Japan

Site Status

Pfizer Investigational Site

Musashino, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setagaya City, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shizuoka, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A9441003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.