Clinical trial NCT01292460: Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Open-angle Glaucoma
Lead sponsor: Santen Oy
Sponsor class: INDUSTRY
First posted: 2011-02-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months
timeFrame: At 3 months
Secondary outcomes:
measure: Change from baseline in average diurnal IOP
timeFrame: At 2 and 6 weeks and 6 months
measure: Change from baseline in timewise IOPs
timeFrame: At 2 weeks, 6 weeks, 3 months and 6 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Eye clinic, University Hospital of Kuopio
city: Oulu
country: Finland
facility: Eye Clinic, University Hospital of Oulu
Study officials:
affiliation: Santen Oy
name: Auli Ropo, M.D.
role: STUDY_DIRECTOR
affiliation: Tampere University
name: Hannu Uusitalo, M.D., Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfeiffer N, Traverso CE, Lorenz K, Saarela V, Liinamaa J, Uusitalo H, Astakhov Y, Boiko E, Ropo A; Preservative-free Tafluprost/Timolol Fixed Combination Study Group. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014 Dec;31(12):1228-46. doi: 10.1007/s12325-014-0163-3. Epub 2014 Dec 2.