This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH.
- Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for
4 weeks or more.
- History of no-response to timolol
- History of trabeculectomy
- History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH). | |||
| Official Title ICMJE | A 8-Week, Randomized, Double-Masked, Parallel Group, Phase III Study Comparing The Efficacy And Safety Of Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH). | |||
| Brief Summary | This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 289 | |||
| Original Enrollment ICMJE | 292 | |||
| Actual Study Completion Date ICMJE | October 2007 | |||
| Actual Primary Completion Date | October 2007 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00383019 | |||
| Other Study ID Numbers ICMJE | A6641050 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | August 2009 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
