The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.
- Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary
glaucoma or ocular hypertension
- IOP of > 21 mm Hg on current treatment
- Any previous or current treatment with latanoprost or other prostaglandin analogues
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension. | |||
| Official Title ICMJE | A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With "Usual Care" Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension | |||
| Brief Summary | The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: latanoprost 0.005% (Xalatan) | |||
| 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 | |||
| Enrollment ICMJE | 329 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | April 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 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 | Finland, Sweden | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00140062 | |||
| Other Study ID Numbers ICMJE | 912-OPT-0091-156 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2008 | |||
| 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
