| 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. |
| |
| 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 |
