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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: PF-04217329; Drug: latanoprost vehicle; Drug: latanoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT00934089

A0191002

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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31 participants in 2 patient groups

PF-04217329 + placebo

Experimental group

Description:

Active study drug + latanoprost vehicle

Treatment:

Drug: latanoprost vehicle

Drug: PF-04217329

Drug: PF-04217329

PF-04217329 + latanoprost

Experimental group

Description:

Active study drug + latanoprost

Treatment:

Drug: latanoprost

Drug: PF-04217329

Drug: PF-04217329