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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: PF-4217329 - Highest Dose; Drug: Latanoprost 0.005%; Drug: PF-04217329 - Lowest Dose; Drug: PF-04217329 - Middle Dose; Drug: PF-04217329 - High Dose; Drug: PF-04217329 - Low Dose; Drug: PF-04217329 - High Middle Dose; Drug: Latanoprost Vehicle; Drug: PF-04217329 - Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00572455

A0191001

Details and patient eligibility

About

To evaluate the safety and efficacy of PF-04217329.

Enrollment: 318 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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318 participants in 14 patient groups

Stage 1: PF-04217329 - Lowest Dose

Experimental group

Treatment:

Drug: PF-04217329 - Lowest Dose

Stage 1: PF-04217329 - Low Dose

Experimental group

Treatment:

Drug: PF-04217329 - Low Dose

Drug: PF-04217329 - Low Dose

Drug: PF-04217329 - Low Dose

Stage 1: PF-04217329 - Middle Dose

Experimental group

Treatment:

Drug: PF-04217329 - Middle Dose

Drug: PF-04217329 - Middle Dose

Drug: PF-04217329 - Middle Dose

Stage 1: PF-04217329 - High Middle Dose

Experimental group

Treatment:

Drug: PF-04217329 - High Middle Dose

Stage 1: PF-04217329 - High Dose

Experimental group

Treatment:

Drug: PF-04217329 - High Dose

Drug: PF-04217329 - High Dose

Drug: PF-04217329 - High Dose

Stage 1: PF-02417329 - Highest Dose

Experimental group

Treatment:

Drug: PF-4217329 - Highest Dose

Stage 1: PF-04217329 - Vehicle

Experimental group

Treatment:

Drug: PF-04217329 - Vehicle

Drug: PF-04217329 - Vehicle

Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle

Experimental group

Treatment:

Drug: Latanoprost Vehicle

Drug: PF-04217329 - Low Dose

Drug: Latanoprost Vehicle

Drug: PF-04217329 - Low Dose

Drug: Latanoprost Vehicle

Drug: PF-04217329 - Low Dose

Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle

Experimental group

Treatment:

Drug: PF-04217329 - Middle Dose

Drug: Latanoprost Vehicle

Drug: PF-04217329 - Middle Dose

Drug: Latanoprost Vehicle

Drug: PF-04217329 - Middle Dose

Drug: Latanoprost Vehicle

Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle

Experimental group

Treatment:

Drug: Latanoprost Vehicle

Drug: PF-04217329 - High Dose

Drug: Latanoprost Vehicle

Drug: PF-04217329 - High Dose

Drug: PF-04217329 - High Dose

Drug: Latanoprost Vehicle

Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%

Experimental group

Treatment:

Drug: PF-04217329 - Low Dose

Drug: Latanoprost 0.005%

Drug: Latanoprost 0.005%

Drug: PF-04217329 - Low Dose

Drug: Latanoprost 0.005%

Drug: Latanoprost 0.005%

Drug: PF-04217329 - Low Dose

Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%

Experimental group

Treatment:

Drug: PF-04217329 - Middle Dose

Drug: PF-04217329 - Middle Dose

Drug: Latanoprost 0.005%

Drug: Latanoprost 0.005%

Drug: PF-04217329 - Middle Dose

Drug: Latanoprost 0.005%

Drug: Latanoprost 0.005%

Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%

Experimental group

Treatment:

Drug: PF-04217329 - High Dose

Drug: Latanoprost 0.005%

Drug: Latanoprost 0.005%

Drug: PF-04217329 - High Dose

Drug: PF-04217329 - High Dose

Drug: Latanoprost 0.005%

Drug: Latanoprost 0.005%

Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%

Experimental group

Treatment:

Drug: PF-04217329 - Vehicle

Drug: Latanoprost 0.005%

Drug: Latanoprost 0.005%

Drug: Latanoprost 0.005%

Drug: Latanoprost 0.005%

Drug: PF-04217329 - Vehicle