Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
NCT00572455
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- Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in 1 or both eyes.
- Qualifying intraocular pressure (IOP) in the same eye at the Eligibility 1 and 2 measurements.
- Closed/barely open anterior chamber angle or a history of acute angle closure in
either eye.
- Anticipate the need to initiate or modify medication (systemic or topical) that is
known to affect intraocular pressure (IOP) during the study period.
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Descriptive Information | ||||
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Brief Title ICMJE | Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure. | |||
Official Title ICMJE | A 2-Stage, Phase 2, Double-Masked, Randomized, Vehicle Controlled, Dose Response Trial Of PF-04217329 And The Marketed Formulation Of Latanoprost In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension. | |||
Brief Summary | To evaluate the safety and efficacy of PF-04217329. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Schachar RA, Raber S, Courtney R, Zhang M. A phase 2, randomized, dose-response trial of taprenepag isopropyl (PF-04217329) versus latanoprost 0.005% in open-angle glaucoma and ocular hypertension. Curr Eye Res. 2011 Sep;36(9):809-17. doi: 10.3109/02713683.2011.593725. | |||
* 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 | 317 | |||
Original Enrollment ICMJE | 256 | |||
Actual Study Completion Date ICMJE | June 2009 | |||
Actual Primary Completion Date | June 2009 (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 | 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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00572455 | |||
Other Study ID Numbers ICMJE | A0191001 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |