A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00383019
First received: September 29, 2006
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH.


Condition Intervention Phase
Glaucoma, Primary Open Angle (POAG)
Ocular Hypertension
Drug: Xalacom (KP2035)
Drug: Xalatan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 8-Week, Randomized, Double-Masked, Parallel Group, Phase III Study Comparing The Efficacy And Safety Of Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change of Intraocular Pressure (IOP) From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of IOP From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Percent Change of IOP From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Number of Subjects With an IOP of <=15 mmHg at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Number of Subjects With an IOP of <=16 mmHg at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Number of Subjects With an IOP of <=17 mmHg at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Number of Subjects With an IOP of <=18 mmHg at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Enrollment: 289
Study Start Date: November 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.

Exclusion Criteria:

  • History of no-response to timolol
  • History of trabeculectomy
  • History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
  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: NCT00383019

  Show 54 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00383019     History of Changes
Other Study ID Numbers: A6641050
Study First Received: September 29, 2006
Results First Received: October 1, 2008
Last Updated: August 3, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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 28, 2014