Status:
COMPLETED
A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Ministry of Health, Malaysia
Conditions:
Ocular Hypertension
Primary Open Angle Glaucoma
Eligibility:
All Genders
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01168414
Start Date
August 1 2010
End Date
February 1 2011
Last Update
July 8 2011
Active Locations (1)
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1
Ophthalmology Department, Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia, 50586