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A Study of Intraocular Pressure (IOP) Reduction in Newly Diagnosed Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01628614
First received: June 25, 2012
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

This is an observational study and will evaluate IOP reduction in newly diagnosed patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline [ Time Frame: Baseline, 14 Weeks ] [ Designated as safety issue: No ]
    Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.


Secondary Outcome Measures:
  • Percentage of Patients With an IOP Reduction ≥10% From Baseline [ Time Frame: Baseline, 14 Weeks ] [ Designated as safety issue: No ]
    Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit.

  • Percentage of Patients With an IOP Reduction ≥20% From Baseline [ Time Frame: Baseline, 14 Weeks ] [ Designated as safety issue: No ]
    Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit.


Enrollment: 4812
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
POAG or OHT
Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
 Other: Standard of Care
Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

  Eligibility

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

Patients with primary open angle glaucoma or ocular hypertension

Criteria

Inclusion Criteria:

  • Newly diagnosed with primary open angle glaucoma or ocular hypertension

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628614

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: NCT01628614     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/028, AGN-EPI-2010-01
Study First Received: June 25, 2012
Results First Received: August 2, 2012
Last Updated: August 2, 2012
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013