Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.

This study is currently recruiting participants.

Verified by Pfizer, April 2009

First Received: November 19, 2008 Last Updated: April 13, 2009 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00801437

Purpose

This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma

Condition	Intervention	Phase
Glaucoma, Open-Angle	Drug: Xalacom	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Non Interventional Study in Slovak Patients With Primary Open Angle Glaucoma and/or Ocular Hypertension Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy Due to Ineffectivity or Intolerance.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence of ocular hyperemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
safety of treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

effectiveness in IOP lowering [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Xalacom treatment patients with primary glaucoma	Drug: Xalacom Xalacom 1 drop into the affected eye daily

Detailed Description:

according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients >18 years with primary open angle glaucoma or ocular hypertension

Criteria

Inclusion Criteria:

primary open angle glaucoma
ocular hypertension
age >18 years

Exclusion Criteria:

bradycardia
obstructive pulmonary disease
hypersensitivity to the drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801437

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Slovakia
Pfizer Investigational Site	Recruiting
Bratislava, Slovakia, 851 03

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6641053
Study First Received:	November 19, 2008
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00801437 History of Changes
Health Authority:	Slovakia: State Institute for Drug Control

Keywords provided by Pfizer:

glaucoma, open-angle, non-interventional study, safety, tolerability

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle

Vascular Diseases
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Cardiovascular Diseases
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009