NCT00572455

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of PF-04217329.

Conditions

• Primary Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
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	Latanoprost Vehicle	1 drop of latanoprost vehicle, 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	Latanoprost Vehicle	1 drop of latanoprost vehicle, 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	Latanoprost 0.005%	1 drop of latanoprost 0.005%, 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	Latanoprost 0.005%	1 drop of latanoprost 0.005%, 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	Latanoprost 0.005%	1 drop of latanoprost 0.005%, 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.

Timeline

• Start date: 2007-12-11
• Primary completion: 2009-06-26
• Completion: 2009-06-26
• First posted: 2007-12-13
• Last updated: 2021-04-30
• Results posted: 2021-04-30

Locations

23 sites across 1 country: United States