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Clinical Trials/NCT01735214
NCT01735214
Completed
Not Applicable

An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments

Allergan0 sites358 target enrollmentMarch 7, 2013

Overview

Phase
Not Applicable
Intervention
Prostaglandin Analogue -Containing IOP-Lowering Therapy
Conditions
Glaucoma, Open-Angle
Sponsor
Allergan
Enrollment
358
Primary Endpoint
Change From Baseline in Intraocular Pressure (IOP) in the Left Eye
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.

Registry
clinicaltrials.gov
Start Date
March 7, 2013
End Date
April 10, 2014
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Allergan
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
  • Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started

Exclusion Criteria

  • Not provided

Arms & Interventions

Patients with POAG or OHT

Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.

Intervention: Prostaglandin Analogue -Containing IOP-Lowering Therapy

Outcomes

Primary Outcomes

Change From Baseline in Intraocular Pressure (IOP) in the Left Eye

Time Frame: Baseline, Week 12

IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.

Change From Baseline in Intraocular Pressure (IOP) in the Right Eye

Time Frame: Baseline, Week 12

IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.

Secondary Outcomes

  • Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale(12 Weeks)
  • Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale(12 Weeks)
  • Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks(12 Weeks)
  • Percentage of Participants Who Continue the New Treatment After 12 Weeks(12 Weeks)
  • Physician Assessment of Adherence to New Treatment Using a 4-Point Scale(12 Weeks)
  • Percentage of Participants Reaching Individual IOP Target After 12 Weeks(12 Weeks)
  • Physician Assessment of Efficacy Using a 5-Point Scale(12 Weeks)

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