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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, Malaysia
• Treatments: Cloprostenol; Timolol

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.