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Completed

NCT Number: NCT01292460

Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies

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.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Open-angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye clinic, University Hospital of Kuopio, Kuopio, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Timolol/ FDC/ Placebo/ Tafluprost

Drug

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).

Primary outcomes

  1. Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months

    Time frame: At 3 months

Secondary outcomes

  1. Change from baseline in average diurnal IOP

    Time frame: At 2 and 6 weeks and 6 months

    Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months

  2. Change from baseline in timewise IOPs

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Santen Oy

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 9, 2011
Registry last updated
Mar 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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