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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


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 IOP

Change from baseline in timewise IOPs


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Aged 18 years or more

- A diagnosis of ocular hypertension or open-angle glaucoma and prior use of timolol or


- Meet specific IOP level at visit 1 (screening), visit 2 (run-in) and visit 3


- 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

Page last updated: August 23, 2015

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