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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)

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ClinicalTrials.gov Identifier: NCT01628614
Recruitment Status : Completed
First Posted : June 27, 2012
Results First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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 or disease Intervention/treatment
Glaucoma, Open-Angle Ocular Hypertension Other: Standard of Care

Study Type : Observational
Actual Enrollment : 4812 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : November 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.



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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:


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

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 Posted: June 27, 2012    Key Record Dates
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