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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168414
First Posted: July 23, 2010
Last Update Posted: July 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ministry of Health, Malaysia
  Purpose
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.

Condition Intervention Phase
Ocular Hypertension Primary Open Angle Glaucoma Drug: Ganfort Drug: Duotrav Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Mean intraocular pressure [ Time Frame: 12 hours ]
    Difference in mean IOP for Ganfort and Duotrav


Enrollment: 42
Study Start Date: August 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ganfort
Fixed combination of Bimatoprost and Timolol
Drug: Ganfort
Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)
Active Comparator: Duotrav
Fixed combination of Travoprost and Timolol
Drug: Duotrav
Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Angle closure glaucoma
  2. Neovascular Galucoma
  3. Secondary open angle glaucoma
  4. Ocular infection/inflammation within 3 months
  5. Ocular surgery within 3 months
  6. History of Refractive surgery
  7. Argon laser trabeculoplasty/Selective laser trabeculoplasty
  8. Pregnancy/nursing
  9. Hypersensitivity to benzalkonium chloride or to any other components of the trial drugs solution.
  10. Patients in whom beta-blockers are contraindicated
  11. Patients on any drugs known to affect IOP.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168414


Locations
Malaysia
Ophthalmology Department, Hospital Kuala Lumpur
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
Sponsors and Collaborators
Ministry of Health, Malaysia
  More Information

Responsible Party: Dr. Lee Ming Yueh, Ophthalmology Department, Hospital Kuala Lumpur
ClinicalTrials.gov Identifier: NCT01168414     History of Changes
Other Study ID Numbers: NMRR-10-466-5929
First Submitted: July 21, 2010
First Posted: July 23, 2010
Last Update Posted: July 8, 2011
Last Verified: July 2010

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Cloprostenol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents