A Study of LUMIGAN® RC in the Clinical Setting

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01833741
• Collaborator: (none)
• Enrollment: 1,137
• Location: 1
• Arm: 1
• Duration (Months): 14.9
• Patients Per Site Per Month: 76.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Primary Open Angle; Ocular Hypertension	Drug: Bimatoprost 0.01%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1137 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimatoprost 0.01% Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.	Drug: Bimatoprost 0.01%; Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.; Other Names: LUMIGAN® RC

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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

1. 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).

2. 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).

3. 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).

4. 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).

5. 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).

6. 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).

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Barrie	Ontario	Canada

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01833741
• Other Study ID Numbers: CLEAR
• First Posted: Apr 17, 2013
• Last Update Posted: Sep 26, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle; Bimatoprost

Study Results

Participant Flow

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Period Title: Overall Study
STARTED	1137
COMPLETED	997
NOT COMPLETED	140

Baseline Characteristics

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Overall Participants	1137
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	66.7 (12.7)
Sex: Female, Male (Count of Participants)
Female	605 53.2%
Male	532 46.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Treatment-Naive Patients With Ocular Hyperemia
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	460
0 (none)	32.2
+0.5 (trace)	39.8
+1 (mild)	21.3
+2 (moderate)	5.9
+3 (severe)	0.9

2. Secondary Outcome

Title	Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients
Description	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).
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

Intent to Treat: all patients who were consented and completed the Baseline visit

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	522
Mean (Standard Deviation) [Percent Change]	-30.9 (15.4)

3. Secondary Outcome

Title	Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
Description	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).
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

Intent to Treat: all patients who were consented and completed the Baseline visit

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	450
Mean (Standard Deviation) [Percent Change]	-16.1 (18.8)

4. Secondary Outcome

Title	Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
Description	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).
Time Frame	Baseline, 12 Weeks

Outcome Measure Data

Analysis Population Description

Intent to Treat: all patients who were consented and completed the Baseline visit

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	165
Mean (Standard Deviation) [Percent Change]	-16.1 (20.4)

5. Secondary Outcome

Title	Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients
Description	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

Outcome Measure Data

Analysis Population Description

Intent to Treat: all patients who were consented and completed the Baseline visit

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	522
Baseline	23.5 (5.8)
Change from Baseline at Week 6	-7.4 (4.9)
Change from Baseline at Week 12	-7.7 (4.9)

6. Secondary Outcome

Title	Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
Description	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

Outcome Measure Data

Analysis Population Description

Intent to Treat: all patients who were consented and completed the Baseline visit

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	450
Baseline	20.3 (4.6)
Change from Baseline at Week 6	-3.5 (4.3)
Change from Baseline at Week 12	-3.7 (4.3)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent to Treat: all patients who were consented and completed the Baseline visit

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	165
Baseline	20.8 (5.2)
Change from Baseline at Week 6	-3.8 (4.7)
Change from Baseline at Week 12	-3.7 (4.6)

8. Secondary Outcome

Title	Percentage of Patients Discontinuing Due to Ocular Adverse Events
Description	Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

Intent to Treat: all patients who were consented and completed the Baseline visit

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	1137
Number [Percentage of Patients]	3.9

9. Primary Outcome

Title	Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	400
0 (none)	35.5
+0.5 (trace)	41.0
+1 (mild)	17.3
+2 (moderate)	6.0
+3 (severe)	0.3

10. Primary Outcome

Title	Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Measure Participants	141
0 (none)	28.4
+0.5 (trace)	36.9
+1 (mild)	24.1
+2 (moderate)	9.2
+3 (severe)	1.4

Adverse Events

Arm/Group Title	Bimatoprost 0.01%
Arm/Group Description	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
All Cause Mortality
	Bimatoprost 0.01%
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bimatoprost 0.01%
	Affected / at Risk (%)	# Events
Total	3/1137 (0.3%)
Cardiac disorders
Cerebrovascular Accident	1/1137 (0.1%)
Myocardial Infarction	1/1137 (0.1%)
General disorders
Malaise	1/1137 (0.1%)
Other (Not Including Serious) Adverse Events
	Bimatoprost 0.01%
	Affected / at Risk (%)	# Events
Total	0/1137 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.