Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma

Bausch + Lomb

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441883

A9441001

Details and patient eligibility

About

This study will evaluate the safety and efficacy of PF 03187207.

Enrollment: 176 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 one or both eyes

Exclusion criteria

-Closed or barely open anterior chamber angle or a history of acute angle closure in either eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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176 participants in 2 patient groups

PF-03187207 and Latanoprost Vehicle

Experimental group

Description:

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

Treatment:

Drug: PF-03187207 and Latanoprost Vehicle

Latanoprost 0.005% and PF-03187207 Vehicle

Active Comparator group

Description:

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

Treatment:

Drug: Latanoprost 0.005% and PF-03187207 Vehicle