A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Completed

• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Interventions: Drug: Bimatoprost

• Registration Number: NCT01646151
• Lead Sponsor: Allergan

Brief Summary

An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-02-18
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-15
• Last Update Submitted: 2014-05-15
• Results First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2580

Inclusion Criteria

• Diagnosis of POAG or OHT
• Previous use of IOP-lowering medication

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bimatoprost	Bimatoprost	Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) at Baseline	Baseline	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.
IOP at Week 12	Week 12	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.

Secondary Outcome Measures

Name	Time	Method
Physician Evaluation of IOP Lowering in the Study Eye(s)	Week 12	IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.
Patient Assessment of Tolerability on a 4-Point Scale	Week 12	Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Physician Assessment of Tolerability on a 4-Point Scale	Week 12	Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.
Physician Assessment of Patient Compliance Compared to Previous Therapy	Week 12	Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.
Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment	12 Weeks	Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.
Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops	Week 12	Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.