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

Santen

Status and phase: Completed; Phase 3

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Tafluprost 0.0015%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918346

77550

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Tafluprost 0.0015% preserved formulation

Experimental group

Treatment:

Drug: Tafluprost 0.0015%

Tafluprost 0.0015% unpreserved formulation

Experimental group

Treatment:

Drug: Tafluprost 0.0015%