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Clinical Trials/NCT01853085
NCT01853085
Completed
Not Applicable

A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

Allergan0 sites1,830 target enrollmentApril 1, 2013

Overview

Phase
Not Applicable
Intervention
Bimatoprost Ophthalmic Solution
Conditions
Glaucoma, Primary Open Angle
Sponsor
Allergan
Enrollment
1830
Primary Endpoint
IOP in the Study Eye at Week 12
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Registry
clinicaltrials.gov
Start Date
April 1, 2013
End Date
March 1, 2014
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Allergan
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary open-angle glaucoma or ocular hypertension
  • Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons

Exclusion Criteria

  • Not provided

Arms & Interventions

Patients with POAG or OHT

Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.

Intervention: Bimatoprost Ophthalmic Solution

Outcomes

Primary Outcomes

IOP in the Study Eye at Week 12

Time Frame: Week 12

IOP is a measurement of the fluid pressure inside the study eye.

Intraocular Pressure (IOP) in the Study Eye at Baseline

Time Frame: Baseline

IOP is a measurement of the fluid pressure inside the study eye.

Secondary Outcomes

  • Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment(12 Weeks)
  • Physician Assessment of Tolerability on a 4-Point Scale(12 Weeks)
  • Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale(Baseline, 12 Weeks)
  • Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale(12 Weeks)
  • Patient Assessment of Tolerability on a 4-Point Scale(12 Weeks)
  • Number of Patients Who Continue Treatment(12 Weeks)

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