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Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143208
First received: August 31, 2005
Last updated: January 18, 2008
Last verified: January 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Glaucoma Ocular Hypertension | Drug: Xalacom | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- IOP change from baseline to the 6-month visit.
Secondary Outcome 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).
| Estimated Enrollment: | 250 |
| Study Start Date: | May 2003 |
| Study Completion Date: | April 2006 |
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143208
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00143208 History of Changes |
| Other Study ID Numbers: |
XALACO-0076-033 |
| Study First Received: | August 31, 2005 |
| Last Updated: | January 18, 2008 |
Additional relevant MeSH terms:
|
Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on July 21, 2017