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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

February 8, 2011
March 12, 2013
February 2011
September 2012   (final data collection date for primary outcome measure)
Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01292460 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ocular Hypertension
  • Open-angle Glaucoma
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 timolol
    Intervention: Drug: Timolol/ FDC/ Placebo/ Tafluprost
  • Experimental: Preservative-free FDC and placebo
    Intervention: Drug: Timolol/ FDC/ Placebo/ Tafluprost
  • Active Comparator: Preservative-free tafluprost
    Intervention: Drug: Timolol/ FDC/ Placebo/ Tafluprost
  • Experimental: Preservative-free FDC
    Intervention: Drug: Timolol/ FDC/ Placebo/ Tafluprost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01292460
201050
No
Santen Oy
Santen Oy
Not Provided
Study Director: Auli Ropo, M.D. Santen Oy
Principal Investigator: Hannu Uusitalo, M.D., Prof. University of Tampere
Santen Oy
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP