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

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ClinicalTrials.gov Identifier: NCT00143208
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 23, 2008
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Xalacom Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2003
Actual Study Completion Date : April 2006

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. IOP change from baseline to the 6-month visit.

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00143208     History of Changes
Other Study ID Numbers: XALACO-0076-033
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: January 23, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases