Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations

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 of Tafluprost and Timolol Eye Drops Given Concomitantly 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-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol.

This study will enroll patients who have ocular hypertension or glaucoma.

The study schedule includes seven visits to the study site and three stages:

• washout of 5 days to 4 weeks depending on current glaucoma medication (if any)
• 6-month study treatment period
• 1-3 weeks post-study period

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: Timolol and Tafluprost; Drug: Fixed Dose Combination of tafluprost and timolol

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Debrecen, Hungary

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
• Meet specific IOP level at visit 1 (screening)and visit 2 (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 greater than 36 mmHg at any time point at screening or baseline
• 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 Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Timolol and Tafluprost; Concomitant administration of preservative-free timolol and tafluprost eye drops	Drug: Timolol and Tafluprost; Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months
Experimental: Fixed Dose Combination of tafluprost and timolol; Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops	Drug: Fixed Dose Combination of tafluprost and timolol; Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops administered once daily. For masking purposes also: vehicle for timolol administered twice daily Treatment period 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Santen Oy
• Investigators: Principal Investigator: Clemens Vass, M.D., Medical University Vienna, Austria; Principal Investigator: Marieta Kostianeva, M.D., University Mulitiprofile Hospital for Active Treatment Sv.Georgi, Bulgaria; Principal Investigator: Eva Ruzickova, M.D., Vseobecna fakultni nemocnice v Praze, Czech Republic; Principal Investigator: Gábor Holló, Semmelweis Egyetem, Hungary; Principal Investigator: Guna Laganovska, M.D., P. Stradina Clinical University Hospital, Latvia; Principal Investigator: Maria L. Ribeiro, M.D., Aibili-Associação p/ Investigação Biomédica e Inovação em Luz e Imagem (AIBILI), Portugal; Principal Investigator: Julián García-Feijóo, M.D., Hospital Clinico San Carlos, Spain

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 28, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimate): March 1, 2011

Study Record Updates

• Last Update Posted (Estimate): June 8, 2012
• Last Update Submitted That Met QC Criteria: June 7, 2012
• Last Verified: June 1, 2012

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: 201051