A Study of LUMIGAN® RC in the Clinical Setting

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01833741

Enrollment

1137

Registered

2013-04-17

Start date

2009-12-31

Completion date

2011-03-31

Last updated

2013-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Primary Open Angle, Ocular Hypertension

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.

Interventions

DRUGBimatoprost 0.01%

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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).
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.
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 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).
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).

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Bimatoprost 0.01% Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.	1,137
Total	1,137

Baseline characteristics

Characteristic	Bimatoprost 0.01%
Age Continuous	66.7 Years STANDARD_DEVIATION 12.7
Sex: Female, Male Female	605 Participants
Sex: Female, Male Male	532 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 1,137
serious Total, serious adverse events	3 / 1,137

Outcome results

Primary

Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia

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.

Time frame: Week 12

Population: All patients who were consented and completed the Baseline visit, and who had data for Week 12

Arm	Measure	Group	Value (NUMBER)
Bimatoprost 0.01%	Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia	0 (none)	28.4 Percentage of Patients
Bimatoprost 0.01%	Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia	+0.5 (trace)	36.9 Percentage of Patients
Bimatoprost 0.01%	Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia	+1 (mild)	24.1 Percentage of Patients
Bimatoprost 0.01%	Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia	+2 (moderate)	9.2 Percentage of Patients
Bimatoprost 0.01%	Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia	+3 (severe)	1.4 Percentage of Patients

Primary

Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia

Time frame: Week 12

Population: All patients who were consented and completed the Baseline visit, and who had data for Week 12

Arm	Measure	Group	Value (NUMBER)
Bimatoprost 0.01%	Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia	0 (none)	35.5 Percentage of Patients
Bimatoprost 0.01%	Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia	+0.5 (trace)	41.0 Percentage of Patients
Bimatoprost 0.01%	Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia	+1 (mild)	17.3 Percentage of Patients
Bimatoprost 0.01%	Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia	+2 (moderate)	6.0 Percentage of Patients
Bimatoprost 0.01%	Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia	+3 (severe)	0.3 Percentage of Patients

Primary

Percentage of Treatment-Naive Patients With Ocular Hyperemia

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.

Time frame: Week 12

Population: All patients who were consented and completed the Baseline visit, and who had data for Week 12

Arm	Measure	Group	Value (NUMBER)
Bimatoprost 0.01%	Percentage of Treatment-Naive Patients With Ocular Hyperemia	0 (none)	32.2 Percentage of Patients
Bimatoprost 0.01%	Percentage of Treatment-Naive Patients With Ocular Hyperemia	+0.5 (trace)	39.8 Percentage of Patients
Bimatoprost 0.01%	Percentage of Treatment-Naive Patients With Ocular Hyperemia	+1 (mild)	21.3 Percentage of Patients
Bimatoprost 0.01%	Percentage of Treatment-Naive Patients With Ocular Hyperemia	+2 (moderate)	5.9 Percentage of Patients
Bimatoprost 0.01%	Percentage of Treatment-Naive Patients With Ocular Hyperemia	+3 (severe)	0.9 Percentage of Patients

Secondary

Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy

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).

Time frame: Baseline, Week 6, Week 12