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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168414
• Other study ID #: NMRR-10-466-5929
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2010
• Last updated: July 7, 2011
• Start date: August 2010
• Est. completion date: February 2011

Study information

• Verified date: July 2010
• Source: Ministry of Health, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• Ganfort
Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)
• Duotrav
Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)

Locations

Country	Name	City	State
Malaysia	Ophthalmology Department, Hospital Kuala Lumpur	Kuala Lumpur	Wilayah Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks	No
Secondary	Mean intraocular pressure	Difference in mean IOP for Ganfort and Duotrav	12 hours	No