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NCT01628614 Clinical Trial

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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01628614
Other study ID # MAF/AGN/OPH/GLA/028
Secondary ID AGN-EPI-2010-01
Status Completed
Phase N/A
First received June 25, 2012
Last updated August 2, 2012
Start date November 2010
Est. completion date July 2011

Study information
Verified date August 2012
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4812
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Newly diagnosed with primary open angle glaucoma or ocular hypertension

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Patients With a Reduction in Intraocular Pressure (IOP) = 5mmHg From Baseline 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. Baseline, 14 Weeks No
Secondary Percentage of Patients With an IOP Reduction =10% From Baseline 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. Baseline, 14 Weeks No
Secondary Percentage of Patients With an IOP Reduction =20% From Baseline 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. Baseline, 14 Weeks No
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