Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.
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| ClinicalTrials.gov Identifier: NCT00143208 |
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Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : January 23, 2008
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Sponsor:
Pfizer
Information provided by:
Pfizer
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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 Type : | Interventional (Clinical Trial) |
| Enrollment : | 250 participants |
| 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 2003 |
| Actual Study Completion Date : | April 2006 |
Resource links provided by the National Library of Medicine
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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00143208 History of Changes |
| Other Study ID Numbers: |
XALACO-0076-033 |
| First Posted: | September 2, 2005 Key Record Dates |
| Last Update Posted: | January 23, 2008 |
| Last Verified: | January 2008 |
Additional relevant MeSH terms:
|
Ocular Hypertension Eye Diseases |