Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.
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ClinicalTrials.gov Identifier: NCT00143208 |
Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : February 21, 2021
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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 |

- IOP change from baseline to the 6-month visit.
- % 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 |
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.

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
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
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: | September 2, 2005 Key Record Dates |
Last Update Posted: | February 21, 2021 |
Last Verified: | January 2008 |
Ocular Hypertension Eye Diseases |