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Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143208
First received: August 31, 2005
Last updated: January 18, 2008
Last verified: January 2008
  Purpose

This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Xalacom
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom (Fixed Combination Of Latanoprost And Timolol) In Patients With Poag Or Oh. A 6-Month, Open, Multi-Center Trial In Italy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • IOP change from baseline to the 6-month visit.

Secondary Outcome Measures:
  • % reduction of IOP change from baseline to the 6-month visit.
  • Proportion of pts achieving different levels of mean % of IOP reduction at the end of the treatment(eg:0%,10%,15%,20%,etc).
  • Proportion of pts who reach specific IOP levels at the end of treatment(eg:16,17,18,19 mmHg,etc).

Estimated Enrollment: 250
Study Start Date: May 2003
Study Completion Date: April 2006
  Eligibility

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

Inclusion Criteria:

  • Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP >= 21 mmHG).
  • Visual acuity >= 20/200.

Exclusion Criteria:

  • Closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
  • Hystory of ALT within 3 months prior to the baseline visit.
  • History of any ocular filtering surgical intervention.
  • Ocular surgery or inflammation/infection within 3 months prior to the baseline visit.
  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: NCT00143208

Locations
Italy
Pfizer Investigational Site
Arezzo, Italy, 52100
Pfizer Investigational Site
Bari, Italy, 74100
Pfizer Investigational Site
Bollate, Italy
Pfizer Investigational Site
Bologna, Italy, 40133
Pfizer Investigational Site
Caserta, Italy, 81100
Pfizer Investigational Site
Catanzaro, Italy, 88100
Pfizer Investigational Site
Conegliano, Italy
Pfizer Investigational Site
Desenzano (BS), Italy, 25015
Pfizer Investigational Site
Ferrara, Italy, 44030
Pfizer Investigational Site
Livorno, Italy, 57100
Pfizer Investigational Site
Massafra, Italy, 74016
Pfizer Investigational Site
Milano, Italy, 20121
Pfizer Investigational Site
Napoli, Italy, 80131
Pfizer Investigational Site
Orbassano, Italy, 10043
Pfizer Investigational Site
Palermo, Italy, 90146
Pfizer Investigational Site
Pavia, Italy, 27100
Pfizer Investigational Site
Pescara, Italy, 65100
Pfizer Investigational Site
Ragusa, Italy, 97100
Pfizer Investigational Site
Roma, Italy, 00157
Pfizer Investigational Site
Roma, Italy, 00189
Pfizer Investigational Site
Sassari, Italy, 07100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00143208     History of Changes
Other Study ID Numbers: XALACO-0076-033
Study First Received: August 31, 2005
Last Updated: January 18, 2008
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014