A Study of the Rate of Progression of Glaucoma During a F... | NCT01629407

Studies
A Study of the Rate of Progression of Glaucoma During a Follow-up Period of Two Years

NCT01629407

Sponsor

Allergan

Status

Completed

Last Update Posted

Jun 20, 2013Estimated

Enrollment

315Actual

Phase

Not provided

Conditions

Glaucoma, Open-Angle

Interventions

Standard of Care

Countries

Spain

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

Jun 2013

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 2009

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jun 25, 2012

First Submission Date that Met QC Criteria

Jun 25, 2012

First Posted Date

Jun 27, 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

Jun 19, 2013

Last Update Posted Date

Jun 20, 2013Estimated

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

This is an epidemiological, non-interventional, prospective study to collect data on glaucoma progression in a routine setting. Patients may receive treatment at the discretion of their physician per local standard of care.

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

315Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glaucoma		Patients with glaucoma	Other: Standard of Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard of Care	Other	Patients with glaucoma treated with standard of care at the discretion of the physician. There is no specific treatment required for this study.	Glaucoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Visual Field		Baseline, 24 Months

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Intraocular Pressure (IOP)		Baseline, 24 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Glaucoma in one or both eyes

Exclusion Criteria:

Participation in a glaucoma therapeutic clinical trial

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

Patients with primary open angle glaucoma in one or both eyes

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Medical Director	Allergan	Study Director

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

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided