Internet-based, Naturalistic Evaluation of Tolerability a... | NCT00487214

Studies
Internet-based, Naturalistic Evaluation of Tolerability and Individual Patient Target Pressures With Bimatoprost 0.03% in Glaucoma

NCT00487214

Sponsor

Allergan

Status

Completed

Last Update Posted

Jun 1, 2011Estimated

Enrollment

361Actual

Phase

Not provided

Conditions

Glaucoma, Open-Angle

Interventions

Not provided

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

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

Jun 2002

Primary Completion Date

Feb 2003Actual

Completion Date

Feb 2003Actual

First Submitted Date

Jun 13, 2007

First Submission Date that Met QC Criteria

Jun 14, 2007

First Posted Date

Jun 15, 2007Estimated

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 31, 2011

Last Update Posted Date

Jun 1, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the range of target IOPs set for glaucoma patients starting monotherapy with bimatoprost and to evaluate patient and physician satisfaction with bimatoprost in "real-world" settings

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

361Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with either open-angle glaucoma or ocular hypertension were eligible if they needed bilateral IOP reduction beyond what was achieved with their current medication, or if they were intolerant of other IOP-lowering medications.

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

Patients with either open-angle glaucoma or ocular hypertension at 41 centers in the United States

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Medical Affairs	Allergan	Study Director

Label	URL
(Link to Clinical Trial Results)	View source

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided