A Study of LUMIGAN® RC in the Clinical Setting

Phase 4

Completed

• Conditions: Glaucoma, Primary Open Angle; Ocular Hypertension
• Interventions: Drug: Bimatoprost 0.01%

• Registration Number: NCT01833741
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-17
• Results First Submitted: 2013-07-09
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-24
• Last Update Submitted: 2013-09-24
• Results First Posted: 2013-09-26
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1137

Inclusion Criteria

• Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
• Determined by the treating physician to require treatment with LUMIGAN® RC

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bimatoprost 0.01%	Bimatoprost 0.01%	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Treatment-Naive Patients With Ocular Hyperemia	Week 12	Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia	Week 12	Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia	Week 12	Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy	Baseline, 12 Weeks	IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients	Baseline, Week 6, Week 12	IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients	Baseline, Week 6, Week 12	IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy	Baseline, Week 6, Week 12	IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients	Baseline, 12 Weeks	IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients	Baseline, 12 Weeks	IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Percentage of Patients Discontinuing Due to Ocular Adverse Events	12 Weeks	Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.