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

Phase 3

Completed

• Conditions: Ocular Hypertension; Primary Open Angle Glaucoma
• Interventions: Drug: Duotrav; Drug: Ganfort

• Registration Number: NCT01168414
• Lead Sponsor: Ministry of Health, Malaysia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Study Start: 2010-08
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Last Update Submitted: 2011-07-07
• Last Update Posted: 2011-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Duotrav	Duotrav	Fixed combination of Travoprost and Timolol
Ganfort	Ganfort	Fixed combination of Bimatoprost and Timolol

Primary Outcome Measures

Name	Time	Method
Mean intraocular pressure of the 12-hour IOP curve	8 weeks	To compare the mean intraocular pressure of the 12-hour IOP curve for Ganfort and Duotrav

Secondary Outcome Measures

Name	Time	Method
Mean intraocular pressure	12 hours	Difference in mean IOP for Ganfort and Duotrav

Trial Locations

Locations (1)

Ophthalmology Department, Hospital Kuala Lumpur; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia