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

Study Overview
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Brief Summary
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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.

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy


Participation Criteria
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Eligibility Criteria
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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: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with POAG or OHT<br>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. | Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraocular Pressure (IOP) in the Right Eye | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. | Baseline, Week 12 | 
| Change From Baseline in Intraocular Pressure (IOP) in the Left Eye | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale | The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported. | 12 Weeks | 
| Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale | The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported. | 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 | The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported. | 12 Weeks | 
| Physician Assessment of Efficacy Using a 5-Point Scale | The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported. | 12 Weeks | 
| Percentage of Participants Reaching Individual IOP Target After 12 Weeks |  | 12 Weeks |