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

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

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