Tafluprost-Timolol Fixed Dose Combination Non-Inferiority Study Against Concomitant Administrations

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 of Tafluprost and Timolol Eye Drops Given Concomitantly in Patients With Open Angle Glaucoma or Ocular Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01306461

Enrollment

401

Registered

2011-03-01

Start date

2011-03-31

Completion date

2012-05-31

Last updated

2012-06-08

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-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol. This study will enroll patients who have ocular hypertension or glaucoma. The study schedule includes seven visits to the study site and three stages: * washout of 5 days to 4 weeks depending on current glaucoma medication (if any) * 6-month study treatment period * 1-3 weeks post-study period

Interventions

DRUGTimolol and Tafluprost

Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months

DRUGFixed Dose Combination of tafluprost and timolol

Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops administered once daily. For masking purposes also: vehicle for timolol administered twice daily Treatment period 6 months

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 * Meet specific IOP level at visit 1 (screening)and visit 2 (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 greater than 36 mmHg at any time point at screening or baseline * 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 intra-ocular pressure (IOP) at 6 months	6 months

Secondary

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

Countries

Hungary

Outcome results

None listed

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