Bimatoprost/Timolol Versus Travoprost/Timolol | NCT01542710

Studies
Bimatoprost/Timolol Versus Travoprost/Timolol

NCT01542710

Sponsor

Kasr El Aini Hospital

Status

Completed

Last Update Posted

Mar 2, 2012Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

Ganfort
Duotrav

Countries

Egypt

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

ID	Type	Description	Link
GFDU-2011
GANDUO-2011	Other Identifier	Cairo University

Status Module

Record Verification Date

Jan 2011

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

Jan 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Feb 6, 2012

First Submission Date that Met QC Criteria

Mar 1, 2012

First Posted Date

Mar 2, 2012Estimated

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

Mar 1, 2012

Last Update Posted Date

Mar 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare 2 fixed combination medications in intraocular pressure lowering.

Detailed Description

PURPOSE: To compare the efficacy of bimatoprost/timolol (BTFC) or travoprost/timolol (TTFC) fixed combinations on intraocular pressure (IOP) reduction in an Egyptian population.

METHODS: Patients with primary open angle glaucoma (POAG) were randomized to receive either BTFC or TTFC. IOPs were measured at baseline, 2 weeks, and 1, 2, 4, and 6 months. The primary outcome measures were the mean change in IOP from baseline

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glaucoma fixed Combination Medications	Experimental		Drug: Ganfort Drug: Duotrav

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ganfort	Drug	Bimatoprost/Timolol fixed combination	Glaucoma fixed Combination Medications

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of drop of intraocular pressures from baseline.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Glaucoma

Exclusion Criteria:

No other ocular diseases

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

Name	Affiliation	Role
Tamer A Macky, MD FRCS	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr El Aini Hospital		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C571755	Ganfort
D000069580	Bimatoprost
C571754	Duotrav

Ancestor Terms

ID	Term
D000577	Amides
D009930	Organic Chemicals
D003008	Cloprostenol
D011461	Prostaglandins F, Synthetic

Browse Leaves

Not provided

Browse Branches

Not provided