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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01168414

Enrollment

Registered

2010-07-23

Start date

2010-08-31

Completion date

2011-02-28

Last updated

2011-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Primary Open Angle Glaucoma

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.

Interventions

DRUGGanfort

Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)

DRUGDuotrav

Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Mean intraocular pressure	12 hours	Difference in mean IOP for Ganfort and Duotrav

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026