NCT01168414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 8, 2011

Status Verified

July 1, 2010

Enrollment Period

5 months

First QC Date

July 21, 2010

Last Update Submit

July 7, 2011

Conditions

Ocular HypertensionPrimary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Mean intraocular pressure

    12 hours

Study Arms (2)

Ganfort

ACTIVE COMPARATOR

Fixed combination of Bimatoprost and Timolol

Drug: Ganfort

Duotrav

ACTIVE COMPARATOR

Fixed combination of Travoprost and Timolol

Drug: Duotrav

Interventions

GanfortDRUG

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

Ganfort
DuotravDRUG

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

Duotrav

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department, Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Interventions

GanfortDuotrav

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 23, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

July 8, 2011

Record last verified: 2010-07

Locations

MY(1)