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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00383019
First Posted: October 2, 2006
Last Update Posted: August 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double
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 ]

Secondary Outcome Measures:
  • Change of IOP From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  • Percent Change of IOP From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]
  • Number of Subjects With an IOP of <=15 mmHg at Week 8 [ Time Frame: Week 8 ]
  • Number of Subjects With an IOP of <=16 mmHg at Week 8 [ Time Frame: Week 8 ]
  • Number of Subjects With an IOP of <=17 mmHg at Week 8 [ Time Frame: Week 8 ]
  • Number of Subjects With an IOP of <=18 mmHg at Week 8 [ Time Frame: Week 8 ]
  • Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]
  • Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383019


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00383019     History of Changes
Other Study ID Numbers: A6641050
First Submitted: September 29, 2006
First Posted: October 2, 2006
Results First Submitted: October 1, 2008
Results First Posted: May 27, 2009
Last Update Posted: August 6, 2009
Last Verified: August 2009

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