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

M

Ministry of Health, Malaysia

Status and phase

Completed
Phase 3

Conditions

Ocular Hypertension
Primary Open Angle Glaucoma

Treatments

Drug: Ganfort
Drug: Duotrav

Study type

Interventional

Funder types

Other

Identifiers

NCT01168414
NMRR-10-466-5929

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Ganfort
Active Comparator group
Description:
Fixed combination of Bimatoprost and Timolol
Treatment:
Drug: Ganfort
Duotrav
Active Comparator group
Description:
Fixed combination of Travoprost and Timolol
Treatment:
Drug: Duotrav

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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