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...
Date First Received: August 31, 2005
Last Updated: January 18, 2008
Verified by: Pfizer, January 2008
Clinical Trial Phase: Phase 4 | Start Date: May 2003
Overall Status: Completed
Estimated Enrollment: 250
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Xalacom
Outcome Measures for this Clinical Trial
Primary Measures
- IOP change from baseline to the 6-month visit.
Secondary 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).
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00143208
Study ID Number: XALACO-0076-033
ClinicalTrials.gov Identifier: NCT00143208
Health Authority: Italy: Ministry of Health
To obtain contact information for a study center near you, click here.
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