Safety and Efficacy Study of DuoTrav APS Versus DuoTrav | NCT00862472

Studies
Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

NCT00862472

Sponsor

Alcon Research

Status

Withdrawn

Last Update Posted

Jan 18, 2012Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Open-angle Glaucoma
Ocular Hypertension

Interventions

DuoTrav APS
DuoTrav

Countries

Not provided

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Management decision not to conduct an additional efficacy study.

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Mar 16, 2009

First Submission Date that Met QC Criteria

Mar 16, 2009

First Posted Date

Mar 17, 2009Estimated

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

Jan 13, 2012

Last Update Posted Date

Jan 18, 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 the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DuoTrav APS	Experimental	DuoTrav APS QD AM	Drug: DuoTrav APS
DuoTrav	Active Comparator	DuoTrav QD AM	Drug: DuoTrav

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DuoTrav APS	Drug	DuoTrav APS QD AM	DuoTrav APS
DuoTrav

Measure	Description	Time Frame
Mean Intraocular Pressure (IOP)		3 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication

Exclusion Criteria:

VA not worse than 0.60
additional clinically relevant ocular or systemic conditions may be excluded

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005901	Glaucoma
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C571754	Duotrav

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided