You are here

Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Artesia, California, 90701 United States
Contact
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
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.

NCT00572455
Pfizer
Completed
Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Familial Persistent Pulmonary Hypertension
NCT01720524
All Genders
0+
Years
Multiple Sites
Pulmonary Arterial Hypertension
NCT02060487
All Genders
18+
Years
Multiple Sites
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
NCT03330405
All Genders
18+
Years
Multiple Sites
Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
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.
To evaluate the safety and efficacy of PF-04217329.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Primary Open Angle Glaucoma
  • Ocular Hypertension
  • Drug: PF-04217329 - Lowest Dose
    1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - Low Dose
    1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - Middle Dose
    1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - High Middle Dose
    1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - High Dose
    1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-4217329 - Highest Dose
    1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - Vehicle
    1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
  • Drug: Latanoprost Vehicle
    1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - Low Dose
    Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - Middle Dose
    Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - High Dose
    Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: Latanoprost 0.005%
    1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - Low Dose
    Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - Middle Dose
    Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - High Dose
    Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - Vehicle
    Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
  • Experimental: Stage 1: PF-04217329 - Lowest Dose
    Intervention: Drug: PF-04217329 - Lowest Dose
  • Experimental: Stage 1: PF-04217329 - Low Dose
    Intervention: Drug: PF-04217329 - Low Dose
  • Experimental: Stage 1: PF-04217329 - Middle Dose
    Intervention: Drug: PF-04217329 - Middle Dose
  • Experimental: Stage 1: PF-04217329 - High Middle Dose
    Intervention: Drug: PF-04217329 - High Middle Dose
  • Experimental: Stage 1: PF-04217329 - High Dose
    Intervention: Drug: PF-04217329 - High Dose
  • Experimental: Stage 1: PF-02417329 - Highest Dose
    Intervention: Drug: PF-4217329 - Highest Dose
  • Experimental: Stage 1: PF-04217329 - Vehicle
    Intervention: Drug: PF-04217329 - Vehicle
  • Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle
    Interventions:
    • Drug: Latanoprost Vehicle
    • Drug: PF-04217329 - Low Dose
  • Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle
    Interventions:
    • Drug: Latanoprost Vehicle
    • Drug: PF-04217329 - Middle Dose
  • Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle
    Interventions:
    • Drug: Latanoprost Vehicle
    • Drug: PF-04217329 - High Dose
  • Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%
    Interventions:
    • Drug: Latanoprost 0.005%
    • Drug: PF-04217329 - Low Dose
  • Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%
    Interventions:
    • Drug: Latanoprost 0.005%
    • Drug: PF-04217329 - Middle Dose
  • Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%
    Interventions:
    • Drug: Latanoprost 0.005%
    • Drug: PF-04217329 - High Dose
  • Experimental: Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%
    Interventions:
    • Drug: Latanoprost 0.005%
    • Drug: PF-04217329 - Vehicle
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.
 
Completed
317
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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.
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
 
 
NCT00572455
A0191001
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now