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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01629407
First received: June 25, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Glaucoma, Open-Angle
 Other: Standard of Care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Visual Field [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]

Enrollment: 315
Study Start Date: June 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Glaucoma
Patients with glaucoma
 Other: Standard of Care
Patients with glaucoma treated with standard of care at the discretion of the physician. There is no specific treatment required for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with primary open angle glaucoma in one or both eyes

Criteria

Inclusion Criteria:

  • Glaucoma in one or both eyes

Exclusion Criteria:

  • Participation in a glaucoma therapeutic clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629407

Locations
Spain
Barcelona, Spain
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01629407     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/015
Study First Received: June 25, 2012
Last Updated: June 25, 2012
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013