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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Oy
ClinicalTrials.gov Identifier:
NCT01306461
First received: February 28, 2011
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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

Condition Intervention Phase
Ocular Hypertension
Open-angle Glaucoma
 Drug: Timolol and Tafluprost
Drug: Fixed Dose Combination of tafluprost and timolol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santen Oy:

Primary Outcome Measures:
  • Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months [ Time Frame: 2 weeks, 6 weeks and 3 months ] [ Designated as safety issue: No ]
  • Change from baseline in timewise IOPs [ Time Frame: 2 weeks, 6 weeks, 3 months and 6 months ] [ Designated as safety issue: No ]
    Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00) at 2 weeks, 6 weeks, 3 months and 6 months


Enrollment: 401
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306461

Locations
Hungary
Debrecen, Hungary
Sponsors and Collaborators
Santen Oy
Investigators
Study Director: Auli Ropo, M.D. Santen Oy
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
  More Information

No publications provided

Responsible Party: Santen Oy
ClinicalTrials.gov Identifier: NCT01306461     History of Changes
Other Study ID Numbers: 201051
Study First Received: February 28, 2011
Last Updated: June 7, 2012
Health Authority: Austria: Agency for Health and Food Safety
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Tetrahydrozoline
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013