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Completed

NCT Number: NCT01168414

A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This is a single-center, cross-over comparison parallel group randomized trial designed to evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8 weeks each.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ophthalmology Department, Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Visual acuity 6/60 or better
  • Patients who are controlled (IOP < 21 mmHg) on non-fixed combination of Latanoprost & Timolol for at least 3 months before the baseline visit and
  • Patients on mono-therapy either Latanoprost or Timolol who are eligible for dual therapy being not satisfactorily controlled (IOP>21mmHG)

Exclusion criteria

  • Angle closure glaucoma
  • Neovascular Galucoma
  • Secondary open angle glaucoma
  • Ocular infection/inflammation within 3 months
  • Ocular surgery within 3 months
  • History of Refractive surgery
  • Argon laser trabeculoplasty/Selective laser trabeculoplasty
  • Pregnancy/nursing
  • Hypersensitivity to benzalkonium chloride or to any other components of the trial drugs solution.
  • Patients in whom beta-blockers are contraindicated
  • Patients on any drugs known to affect IOP.

Treatment and study plan

Ganfort

Drug

Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)

Duotrav

Drug

Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)

Primary outcomes

  1. Mean intraocular pressure of the 12-hour IOP curve

    Time frame: 8 weeks

    To compare the mean intraocular pressure of the 12-hour IOP curve for Ganfort and Duotrav

Secondary outcomes

  1. Mean intraocular pressure

    Time frame: 12 hours

    Difference in mean IOP for Ganfort and Duotrav

Sponsors and collaborators

Lead sponsor

Ministry of Health, Malaysia

Other Gov

Registry information

Official study title

A Randomized, Comparison of the Effects of Ganfort and Duotrav on Intraocular Pressure in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Open Label/Evaluator-blind/Cross-over Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 23, 2010
Registry last updated
Jul 8, 2011

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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