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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Oy
• Treatments: Ophthalmic Solutions; Tetrahydrozoline

Criteria

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