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

Completed

• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Interventions: Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy

• Registration Number: NCT01735214
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-28
• Study Start: 2013-03-07
• Primary Completion: 2014-04-10
• Study Completion: 2014-04-10
• Results First Submitted: 2015-04-10
• Results First Submitted QC: 2015-04-10
• Results First Posted: 2015-04-27
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

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

Read More

Exclusion Criteria

• None

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with POAG or OHT	Prostaglandin Analogue -Containing IOP-Lowering Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP) in the Left Eye	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	Baseline, Week 12	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
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale	12 Weeks	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.
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale	12 Weeks	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.
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	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.
Percentage of Participants Reaching Individual IOP Target After 12 Weeks	12 Weeks
Physician Assessment of Efficacy Using a 5-Point Scale	12 Weeks	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.