Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies

A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those Given Individually in Patients With Open Angle Glaucoma or Ocular Hypertension

The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin.

The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: Timolol/ FDC/ Placebo/ Tafluprost

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70210
    • Eye clinic, University Hospital of Kuopio
  • Oulu, Finland, 90029 OYS
    • Eye Clinic, University Hospital of Oulu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18 years or more
• A diagnosis of ocular hypertension or open-angle glaucoma and prior use of timolol or prostaglandin.
• Meet specific IOP level at visit 1 (screening), visit 2 (run-in) and visit 3 (baseline).
• Meet specific visual acuity score
• Are willing to follow instructions
• Have provided a written informed consent

Exclusion Criteria:

• Females who are pregnant, nursing or planning pregnancy
• IOP of 35 mmHg or greater
• Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye
• Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse)or to wash-out medication brinzolamide
• Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening
• 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 patient safety or study parameters
• Current participation in another clinical trial within the last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Preservative-free timolol	Drug: Timolol/ FDC/ Placebo/ Tafluprost; Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
EXPERIMENTAL: Preservative-free FDC and placebo	Drug: Timolol/ FDC/ Placebo/ Tafluprost; Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
ACTIVE_COMPARATOR: Preservative-free tafluprost	Drug: Timolol/ FDC/ Placebo/ Tafluprost; Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
EXPERIMENTAL: Preservative-free FDC	Drug: Timolol/ FDC/ Placebo/ Tafluprost; Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in average diurnal IOP	Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months	At 2 and 6 weeks and 6 months
Change from baseline in timewise IOPs	Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00)	At 2 weeks, 6 weeks, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Santen Oy
• Investigators: Principal Investigator: Hannu Uusitalo, M.D., Prof., Tampere University

Publications and helpful links

General Publications

• Pfeiffer N, Traverso CE, Lorenz K, Saarela V, Liinamaa J, Uusitalo H, Astakhov Y, Boiko E, Ropo A; Preservative-free Tafluprost/Timolol Fixed Combination Study Group. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014 Dec;31(12):1228-46. doi: 10.1007/s12325-014-0163-3. Epub 2014 Dec 2.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: February 8, 2011
• First Submitted That Met QC Criteria: February 8, 2011
• First Posted (ESTIMATE): February 9, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 13, 2013
• Last Update Submitted That Met QC Criteria: March 12, 2013
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol
• Other Study ID Numbers: 201050