Safety and Efficacy Study of Brimonidine/Timolol Fixed Co... | NCT00332384

Studies
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

NCT00332384

Sponsor

Allergan

Status

Completed

Last Update Posted

May 30, 2011Estimated

Enrollment

573Actual

Phase

Phase 3

Conditions

Ocular Hypertension

Interventions

brimonidine/timolol fixed combination

Countries

United States

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

May 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 2000

Primary Completion Date

Nov 2001Actual

Completion Date

Nov 2001Actual

First Submitted Date

May 30, 2006

First Submission Date that Met QC Criteria

May 30, 2006

First Posted Date

Jun 1, 2006Estimated

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

May 27, 2011

Last Update Posted Date

May 30, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

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

573Actual

Name	Type	Description	Arm Group Labels	Other Names
brimonidine/timolol fixed combination	Drug

Measure	Description	Time Frame
IOP

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

Uncontrolled medical conditions
contraindication to beta-adrenoceptor antagonist or brimonidine therapy

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Newport Beach	California		United States

ID	Term
D009798	Ocular Hypertension

ID	Term
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000068438	Brimonidine Tartrate

Ancestor Terms

ID	Term
D011810	Quinoxalines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided