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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014