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

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ClinicalTrials.gov Identifier: NCT01168414
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : July 8, 2011
Sponsor:
Information provided by:
Ministry of Health, Malaysia

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Ocular Hypertension Primary Open Angle Glaucoma Drug: Ganfort Drug: Duotrav Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
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)


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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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Malaysia
Ophthalmology Department, Hospital Kuala Lumpur
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
Sponsors and Collaborators
Ministry of Health, Malaysia
More Information
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Responsible Party: Dr. Lee Ming Yueh, Ophthalmology Department, Hospital Kuala Lumpur
ClinicalTrials.gov Identifier: NCT01168414    
Other Study ID Numbers: NMRR-10-466-5929
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: July 8, 2011
Last Verified: July 2010
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
 Vascular Diseases
Cardiovascular Diseases
Eye Diseases