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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01292460

Enrollment

600

Registered

2011-02-09

Start date

2011-02-28

Completion date

2012-09-30

Last updated

2013-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open-angle Glaucoma

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.

Interventions

DRUGTimolol/ 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months	At 3 months

Secondary

Measure	Time frame	Description
Change from baseline in average diurnal IOP	At 2 and 6 weeks and 6 months	Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months
Change from baseline in timewise IOPs	At 2 weeks, 6 weeks, 3 months and 6 months	Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026