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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00143208
• Collaborator: (none)
• Enrollment: 250
• Locations: 21
• Duration (Months): 35
• Patients Per Site: 11.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

• Study Type: Interventional
• 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 1, 2003
• Actual Study Completion Date: Apr 1, 2006

Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Arezzo		Italy	52100
2	Pfizer Investigational Site	Bari		Italy	74100
3	Pfizer Investigational Site	Bollate		Italy
4	Pfizer Investigational Site	Bologna		Italy	40133
5	Pfizer Investigational Site	Caserta		Italy	81100
6	Pfizer Investigational Site	Catanzaro		Italy	88100
7	Pfizer Investigational Site	Conegliano		Italy
8	Pfizer Investigational Site	Desenzano (BS)		Italy	25015
9	Pfizer Investigational Site	Ferrara		Italy	44030
10	Pfizer Investigational Site	Livorno		Italy	57100
11	Pfizer Investigational Site	Massafra		Italy	74016
12	Pfizer Investigational Site	Milano		Italy	20121
13	Pfizer Investigational Site	Napoli		Italy	80131
14	Pfizer Investigational Site	Orbassano		Italy	10043
15	Pfizer Investigational Site	Palermo		Italy	90146
16	Pfizer Investigational Site	Pavia		Italy	27100
17	Pfizer Investigational Site	Pescara		Italy	65100
18	Pfizer Investigational Site	Ragusa		Italy	97100
19	Pfizer Investigational Site	Roma		Italy	00157
20	Pfizer Investigational Site	Roma		Italy	00189
21	Pfizer Investigational Site	Sassari		Italy	07100

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00143208
• Other Study ID Numbers: XALACO-0076-033
• First Posted: Sep 2, 2005
• Last Update Posted: Feb 21, 2021
• Last Verified: Jan 1, 2008

• Additional relevant MeSH terms: Ocular Hypertension

Study Results

No Results Posted as of Feb 21, 2021