A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329

NCT00934089

Last updated date
Study Location
Pfizer Investigational Site
Cypress, California, 90630, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Open-Angle Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 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 or ocular hypertension in one or both eyes

- Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye at 8 AM after discontinuing previous glaucoma treatment

- Visual acuity correctable to 20/100 or better in each eye.

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.


- Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic
retinopathy, macular degeneration) in either eye.


- Advanced glaucoma or a history of severe central visual field loss in either eye.


- History of ocular surgery or trauma in either eye within 6 months of the screening
visit.


- History of ocular infection, ocular inflammation, or laser surgery in either eye
within 3 months of the screening visit.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
Official Title  ICMJE A Phase 2, Single-Masked, Randomized, Crossover Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329 Alone and In Combination With Latanoprost
Brief Summary This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: PF-04217329
    Topical ocular solution, once-daily for 14 days
  • Drug: latanoprost vehicle
    Topical ocular solution, once-daily for 14 days
  • Drug: latanoprost
    Topical ocular solution, once-daily for 14 days
    Other Name: Xalatan
Study Arms  ICMJE
  • Experimental: PF-04217329 + placebo
    Active study drug + latanoprost vehicle
    Interventions:
    • Drug: PF-04217329
    • Drug: latanoprost vehicle
  • Experimental: PF-04217329 + latanoprost
    Active study drug + latanoprost
    Interventions:
    • Drug: PF-04217329
    • Drug: latanoprost
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
 (submitted: November 11, 2010)
31
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2009)
32
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes
  • Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye at 8 AM after discontinuing previous glaucoma treatment
  • Visual acuity correctable to 20/100 or better in each eye.

Exclusion Criteria:

  • Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
  • Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.
  • Advanced glaucoma or a history of severe central visual field loss in either eye.
  • History of ocular surgery or trauma in either eye within 6 months of the screening visit.
  • History of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 NCT00934089
Other Study ID Numbers  ICMJE A0191002
Has Data Monitoring Committee No
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP