Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies
Information source: Santen Oy
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ocular Hypertension; Open-angle Glaucoma
Intervention: Timolol/ FDC/ Placebo/ Tafluprost (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Santen Oy Official(s) and/or principal investigator(s): Auli Ropo, M.D., Study Director, Affiliation: Santen Oy Hannu Uusitalo, M.D., Prof., Principal Investigator, Affiliation: University of Tampere
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months
Secondary outcome: Change from baseline in average diurnal IOPChange from baseline in timewise IOPs
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Eye clinic, University Hospital of Kuopio, Kuopio 70210, Finland
Eye Clinic, University Hospital of Oulu, Oulu 90029 OYS, Finland
Additional Information
Starting date: February 2011
Last updated: March 12, 2013
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