Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation

Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension

The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure [IOP]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension.

The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.

Inclusion Criteria:

• Age 18 years or more
• A diagnosis of open angle glaucoma or ocular hypertension
• Prior use of prostaglandin(s)
• Intra ocular pressure of 22-34 mmHg in at least one eye

Exclusion Criteria:

• Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
• Previous participation in any clinical trial in which tafluprost was an investigational drug or use of contact lenses at screening or during the study
• Presence of any abnormality or significant illness that could be expected to interfere with the study