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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143208
• Other study ID #: XALACO-0076-033
• Status: Completed
• Phase: Phase 4
• Start date: May 2003
• Est. completion date: April 2006

Study information

• Verified date: January 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Xalacom

Locations

Country	Name	City	State
Italy	Pfizer Investigational Site	Arezzo
Italy	Pfizer Investigational Site	Bari
Italy	Pfizer Investigational Site	Bollate
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Caserta
Italy	Pfizer Investigational Site	Catanzaro
Italy	Pfizer Investigational Site	Conegliano
Italy	Pfizer Investigational Site	Desenzano (BS)
Italy	Pfizer Investigational Site	Ferrara
Italy	Pfizer Investigational Site	Livorno
Italy	Pfizer Investigational Site	Massafra
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Napoli
Italy	Pfizer Investigational Site	Orbassano
Italy	Pfizer Investigational Site	Palermo
Italy	Pfizer Investigational Site	Pavia
Italy	Pfizer Investigational Site	Pescara
Italy	Pfizer Investigational Site	Ragusa
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Sassari

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP change from baseline to the 6-month visit.
Secondary	% reduction of IOP change from baseline to the 6-month visit.
Secondary	Proportion of pts achieving different levels of mean % of IOP reduction at the end of the treatment(eg:0%,10%,15%,20%,etc).
Secondary	Proportion of pts who reach specific IOP levels at the end of treatment(eg:16,17,18,19 mmHg,etc).

External Links

•   To obtain contact information for a study center near you, click here.