Clinical trial NCT00441883: Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma
Official title: A Phase 2, 28 Day Parallel-Group, Double-Masked, Dose-Finding Study Comparing the Safety and Efficacy of PF-03187207 to Latanoprost
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Pigmentary Glaucoma
Pseudoexfoliative Glaucoma
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
Collaborators: name: NicOx Inc.
First posted: 2007-03-01
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28
timeFrame: Baseline, 28 days
Secondary outcomes:
measure: Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits
timeFrame: Baseline, Day 7, Day 14, and Day 21
measure: Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28
timeFrame: 28 days
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Petaluma
country: United States
facility: Pfizer Investigational Site
state: California
city: Poway
country: United States
facility: Pfizer Investigational Site
state: California
city: Danbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: High Point
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Cranberry Township
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Kenneth Harper
role: STUDY_DIRECTOR
References: