An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 358
- Primary Endpoint
- Change From Baseline in Intraocular Pressure (IOP) in the Left Eye
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
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)