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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:
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT01168414
First received: July 21, 2010
Last updated: July 7, 2011
Last verified: July 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

Drug Information available for: Timolol
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168414

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

No publications provided

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
Study First Received: July 21, 2010
Last Updated: July 7, 2011
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
 Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013