A Study of Ganfort Versus Duotrav in Patients With Primar... | NCT01168414

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

NCT01168414

Sponsor

Ministry of Health, Malaysia

Status

Completed

Last Update Posted

Jul 8, 2011Estimated

Enrollment

42Actual

Phase

Phase 3

Conditions

Ocular Hypertension
Primary Open Angle Glaucoma

Interventions

Ganfort
Duotrav

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Jul 21, 2010

First Submission Date that Met QC Criteria

Jul 22, 2010

First Posted Date

Jul 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2011

Last Update Posted Date

Jul 8, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ganfort	Active Comparator	Fixed combination of Bimatoprost and Timolol	Drug: Ganfort
Duotrav	Active Comparator	Fixed combination of Travoprost and Timolol	Drug: Duotrav

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ganfort	Drug	Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)	Ganfort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology Department, Hospital Kuala Lumpur		Kuala Lumpur	Kuala Lumpur	50586	Malaysia

Condition Browse Module

MeSH Terms

ID	Term
D009798	Ocular Hypertension
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005128	Eye Diseases
D005901	Glaucoma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C571755	Ganfort
C571754	Duotrav

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided