NCT01629407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

3.9 years

First QC Date

June 25, 2012

Last Update Submit

June 19, 2013

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Visual Field

    Baseline, 24 Months

Secondary Outcomes (1)

  • Change from Baseline in Intraocular Pressure (IOP)

    Baseline, 24 Months

Study Arms (1)

Glaucoma

Patients with glaucoma

Other: Standard of Care

Interventions

Standard of CareOTHER

Patients with glaucoma treated with standard of care at the discretion of the physician. There is no specific treatment required for this study.

Glaucoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with primary open angle glaucoma in one or both eyes

You may qualify if:

  • Glaucoma in one or both eyes

You may not qualify if:

  • Participation in a glaucoma therapeutic clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Barcelona, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 27, 2012

Study Start

June 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

ES(1)