A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy

Completed

• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Interventions: Drug: Any Fixed Combination Therapy

• Registration Number: NCT01637246
• Lead Sponsor: Allergan

Brief Summary

This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-11
• Status Verified: 2012-08
• Results First Submitted: 2012-08-21
• Results First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Results First Posted: 2012-09-21
• Last Update Posted: 2012-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4385

Inclusion Criteria

• Diagnosis of glaucoma or ocular hypertension
• Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks

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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	Any Fixed Combination Therapy	Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP)	Baseline, 12 Weeks	IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

Secondary Outcome Measures

Name	Time	Method
Physician Assessment of Tolerability Using a 4-Point Scale	12 Weeks	Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.
Percentage of Patients Who Maintained Better Compliance With Treatment	12 Weeks	Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).
Patient Assessment of Tolerability Using a 4-Point Scale	12 Weeks	Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.
Percentage of Patients Continuing on Therapy After 12 Weeks	12 Weeks	Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.