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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:
ClinicalTrials.gov Identifier:
NCT01628614
First Posted: June 27, 2012
Last Update Posted: September 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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:


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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628614


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01628614     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/028
AGN-EPI-2010-01 ( Other Identifier: Allergan )
First Submitted: June 25, 2012
First Posted: June 27, 2012
Results First Submitted: August 2, 2012
Results First Posted: September 5, 2012
Last Update Posted: September 5, 2012
Last Verified: August 2012

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