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

Primary Purpose

Ocular Hypertension, Primary Open Angle Glaucoma

Status
Completed
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
Ganfort
Duotrav
Sponsored by
Ministry of Health, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ophthalmology Department, Hospital Kuala Lumpur

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ganfort

Duotrav

Arm Description

Fixed combination of Bimatoprost and Timolol

Fixed combination of Travoprost and Timolol

Outcomes

Primary Outcome Measures

Mean intraocular pressure of the 12-hour IOP curve
To compare the mean intraocular pressure of the 12-hour IOP curve for Ganfort and Duotrav

Secondary Outcome Measures

Mean intraocular pressure
Difference in mean IOP for Ganfort and Duotrav

Full Information

First Posted
July 21, 2010
Last Updated
July 7, 2011
Sponsor
Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT01168414
Brief Title
A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Malaysia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Primary Open Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ganfort
Arm Type
Active Comparator
Arm Description
Fixed combination of Bimatoprost and Timolol
Arm Title
Duotrav
Arm Type
Active Comparator
Arm Description
Fixed combination of Travoprost and Timolol
Intervention Type
Drug
Intervention Name(s)
Ganfort
Intervention Description
Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)
Intervention Type
Drug
Intervention Name(s)
Duotrav
Intervention Description
Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)
Primary Outcome Measure Information:
Title
Mean intraocular pressure of the 12-hour IOP curve
Description
To compare the mean intraocular pressure of the 12-hour IOP curve for Ganfort and Duotrav
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Mean intraocular pressure
Description
Difference in mean IOP for Ganfort and Duotrav
Time Frame
12 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Facility Information:
Facility Name
Ophthalmology Department, Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50586
Country
Malaysia

12. IPD Sharing Statement

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

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