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

This study has been completed.
Sponsor:
Collaborator:
NicOx Inc.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00441883
First received: February 27, 2007
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertension
Pigmentary Glaucoma
Pseudoexfoliative Glaucoma
Drug: PF-03187207 and Latanoprost Vehicle
Drug: Latanoprost 0.005% and PF-03187207 Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, 28 Day Parallel-Group, Double-Masked, Dose-Finding Study Comparing the Safety and Efficacy of PF-03187207 to Latanoprost

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Change in diurnal intraocular pressure (IOP) at day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in resting pulse and blood pressure, and clinical laboratories throughout the study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Determine the impact of dose timing [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change from baseline IOP at the Day 7, 14, 21, and 28 visits [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Proportion of patients at target IOP across all study visits [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change in safety assessments, ocular and systemic adverse events throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change in refraction, visual acuity, visual fields throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change in pupil diameter, biomicroscopic examination throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change in ophthalmoscopy, gonioscopy, pachymetry throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 242
Study Start Date: March 2007
Study Completion Date: July 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-03187207 and Latanoprost Vehicle
One drop of each, once daily in study eye for 28 days
Drug: PF-03187207 and Latanoprost Vehicle
Active Comparator: Latanoprost 0.005% and PF-03187207 Vehicle
One drop of each, once daily in study eye for 28 days
Drug: Latanoprost 0.005% and PF-03187207 Vehicle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441883

Locations
United States, California
Pfizer Investigational Site
Artesia, California, United States, 90701
Pfizer Investigational Site
Newport Beach, California, United States, 92663
Pfizer Investigational Site
Petaluma, California, United States, 94954
Pfizer Investigational Site
Poway, California, United States, 92064
United States, Connecticut
Pfizer Investigational Site
Danbury, Connecticut, United States, 06810-4004
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32204
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30339
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47710
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40217
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
High Point, North Carolina, United States, 27262
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Pfizer Investigational Site
Cranberry Township, Pennsylvania, United States, 16066
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15238
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Sponsors and Collaborators
Bausch & Lomb Incorporated
NicOx Inc.
Investigators
Study Director: Kenneth Harper Bausch & Lomb Incorporated
  More Information

Additional Information:
No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00441883     History of Changes
Other Study ID Numbers: A9441001
Study First Received: February 27, 2007
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014