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Completed

NCT Number: NCT01306461

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

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

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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

Debrecen, Hungary

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
  • 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

Treatment and study plan

Timolol and Tafluprost

Drug

Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily

Treatment period 6 months

Fixed Dose Combination of tafluprost and timolol

Drug

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

Primary outcomes

  1. Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months

    Time frame: 6 months

Secondary outcomes

  1. Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months

    Time frame: 2 weeks, 6 weeks and 3 months

  2. Change from baseline in timewise IOPs

    Time frame: 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

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 1, 2011
Registry last updated
Jun 8, 2012

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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