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

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Other: Standard of Care

• Registration Number: NCT01628614
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-27
• Status Verified: 2012-08
• Results First Submitted: 2012-08-02
• Results First Submitted QC: 2012-08-02
• Last Update Submitted: 2012-08-02
• Results First Posted: 2012-09-05
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4812

Inclusion Criteria

• Newly diagnosed with primary open angle glaucoma or ocular hypertension

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POAG or OHT	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

Name	Time	Method
Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline	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

Name	Time	Method
Percentage of Patients With an IOP Reduction ≥10% From Baseline	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	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.