Trial | NCT01306461  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tafluprost timolol ...

  • Study Participants

    401
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
Study Started
Mar 31
2011
Primary Completion
Apr 30
2012
Study Completion
May 31
2012
Last Update
Jun 08
2012
Estimate

Drug Timolol and Tafluprost

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

Drug Fixed 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

Timolol and Tafluprost Active Comparator

Concomitant administration of preservative-free timolol and tafluprost eye drops

Fixed Dose Combination of tafluprost and timolol Experimental

Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops

Criteria 

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
No Results Posted