A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.

Bausch + Lomb

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: PF-03187207 Vehicle; Drug: Latanoprost 0.005%; Drug: Latanoprost Vehicle; Drug: PF-03187207

Study type: Interventional

Funder types: Industry

Identifiers

NCT00595101

A9441003

Details and patient eligibility

About

To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension

Enrollment: 117 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Man or woman at least 20 years of age
• Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.

Exclusion criteria

• Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
• Contraindications to latanoprost and nitric oxide treatment
• Known latanoprost non-responders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 4 patient groups

PF-03187207 High Dose and Latanoprost Vehicle

Experimental group

Description:

A single drop of each, once daily in study eye for 28 days

Treatment:

Drug: Latanoprost Vehicle

Drug: PF-03187207

Latanoprost 0.005% and PF-03187207 Vehicle

Experimental group

Description:

A single drop of each, once daily in study eye for 28 days

Treatment:

Drug: Latanoprost 0.005%

Drug: PF-03187207 Vehicle

PF-03187207 Medium Dose and Latanoprost Vehicle

Experimental group

Description:

A single drop of each, once daily in study eye for 28 days

Treatment:

Drug: Latanoprost Vehicle

Drug: PF-03187207

PF-03187207 Low Dose and Latanoprost Vehicle

Experimental group

Description:

A single drop of each, once daily in study eye for 28 days

Treatment:

Drug: Latanoprost Vehicle

Drug: PF-03187207