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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Cypress, California, 90630 United States
Contact
1-800-718-1021
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.

NCT00934089
Pfizer
Completed
A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329

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A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Glaucoma, Open-Angle
  • Ocular Hypertension
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
June 2010
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00934089
A0191002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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