A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Information source: Ministry of Health, Malaysia
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ocular Hypertension; Primary Open Angle Glaucoma
Intervention: Ganfort (Drug); Duotrav (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Ministry of Health, Malaysia
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean intraocular pressure of the 12-hour IOP curve
Secondary outcome: Mean intraocular pressure
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Ophthalmology Department, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan 50586, Malaysia
Additional Information
Starting date: August 2010
Last updated: July 22, 2010
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