Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
NCT00572455
Last updated date
ABOUT THIS STUDY
To evaluate the safety and efficacy of PF-04217329.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Primary Open Angle Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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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Primary Open Angle Glaucoma, Ocular HypertensionSafety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
NCT00572455
- Artesia, California
- Newport Beach, California
- Petaluma, California
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- Daytona Beach, Florida
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| 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 |
| |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| 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:
| |||
| 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 | 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 |
| |||
| 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 | ||||