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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Oy
ClinicalTrials.gov Identifier:
NCT01292460
First received: February 8, 2011
Last updated: March 12, 2013
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Ocular Hypertension
Open-angle Glaucoma
Drug: Timolol/ FDC/ Placebo/ Tafluprost
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 Given Individually in Patients With Open Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Santen Oy:

Primary Outcome Measures:
  • Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months [ Time Frame: At 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in average diurnal IOP [ Time Frame: At 2 and 6 weeks and 6 months ] [ Designated as safety issue: No ]
    Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months

  • Change from baseline in timewise IOPs [ Time Frame: At 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, 20:00)


Estimated Enrollment: 600
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292460

Locations
Finland
Eye clinic, University Hospital of Kuopio
Kuopio, Finland, 70210
Eye Clinic, University Hospital of Oulu
Oulu, Finland, 90029 OYS
Sponsors and Collaborators
Santen Oy
Investigators
Study Director: Auli Ropo, M.D. Santen Oy
Principal Investigator: Hannu Uusitalo, M.D., Prof. University of Tampere
  More Information

No publications provided

Responsible Party: Santen Oy
ClinicalTrials.gov Identifier: NCT01292460     History of Changes
Other Study ID Numbers: 201050
Study First Received: February 8, 2011
Last Updated: March 12, 2013
Health Authority: Finland: Finnish Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: Medicines Evaluation Board (MEB)
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Estonia: The State Agency of Medicine
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
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

ClinicalTrials.gov processed this record on July 20, 2014