Trial Outcomes & Findings for A Study of LUMIGAN® RC in the Clinical Setting (NCT NCT01833741)
NCT ID: NCT01833741
Last Updated: 2013-09-26
Results Overview
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.
COMPLETED
PHASE4
1137 participants
Week 12
2013-09-26
Participant Flow
Participant milestones
| Measure |
Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
1137
|
|
Overall Study
COMPLETED
|
997
|
|
Overall Study
NOT COMPLETED
|
140
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LUMIGAN® RC in the Clinical Setting
Baseline characteristics by cohort
| Measure |
Bimatoprost 0.01%
n=1137 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Age Continuous
|
66.7 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
605 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
532 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All patients who were consented and completed the Baseline visit, and who had data for 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.
Outcome measures
| Measure |
Bimatoprost 0.01%
n=460 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Percentage of Treatment-Naive Patients With Ocular Hyperemia
0 (none)
|
32.2 Percentage of Patients
|
|
Percentage of Treatment-Naive Patients With Ocular Hyperemia
+0.5 (trace)
|
39.8 Percentage of Patients
|
|
Percentage of Treatment-Naive Patients With Ocular Hyperemia
+1 (mild)
|
21.3 Percentage of Patients
|
|
Percentage of Treatment-Naive Patients With Ocular Hyperemia
+2 (moderate)
|
5.9 Percentage of Patients
|
|
Percentage of Treatment-Naive Patients With Ocular Hyperemia
+3 (severe)
|
0.9 Percentage of Patients
|
PRIMARY outcome
Timeframe: Week 12Population: All patients who were consented and completed the Baseline visit, and who had data for 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.
Outcome measures
| Measure |
Bimatoprost 0.01%
n=400 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
0 (none)
|
35.5 Percentage of Patients
|
|
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
+0.5 (trace)
|
41.0 Percentage of Patients
|
|
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
+1 (mild)
|
17.3 Percentage of Patients
|
|
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
+2 (moderate)
|
6.0 Percentage of Patients
|
|
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
+3 (severe)
|
0.3 Percentage of Patients
|
PRIMARY outcome
Timeframe: Week 12Population: All patients who were consented and completed the Baseline visit, and who had data for 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.
Outcome measures
| Measure |
Bimatoprost 0.01%
n=141 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
0 (none)
|
28.4 Percentage of Patients
|
|
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
+0.5 (trace)
|
36.9 Percentage of Patients
|
|
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
+1 (mild)
|
24.1 Percentage of Patients
|
|
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
+2 (moderate)
|
9.2 Percentage of Patients
|
|
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
+3 (severe)
|
1.4 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Intent to Treat: all patients who were consented and completed the Baseline visit
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).
Outcome measures
| Measure |
Bimatoprost 0.01%
n=522 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients
|
-30.9 Percent Change
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Intent to Treat: all patients who were consented and completed the Baseline visit
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).
Outcome measures
| Measure |
Bimatoprost 0.01%
n=450 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
|
-16.1 Percent Change
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Intent to Treat: all patients who were consented and completed the Baseline visit
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).
Outcome measures
| Measure |
Bimatoprost 0.01%
n=165 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
|
-16.1 Percent Change
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Intent to Treat: all patients who were consented and completed the Baseline visit
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).
Outcome measures
| Measure |
Bimatoprost 0.01%
n=522 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients
Baseline
|
23.5 Millimeters of Mercury (mmHg)
Standard Deviation 5.8
|
|
Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients
Change from Baseline at Week 6
|
-7.4 Millimeters of Mercury (mmHg)
Standard Deviation 4.9
|
|
Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients
Change from Baseline at Week 12
|
-7.7 Millimeters of Mercury (mmHg)
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Intent to Treat: all patients who were consented and completed the Baseline visit
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).
Outcome measures
| Measure |
Bimatoprost 0.01%
n=450 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
Baseline
|
20.3 Millimeters of Mercury (mmHg)
Standard Deviation 4.6
|
|
Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
Change from Baseline at Week 6
|
-3.5 Millimeters of Mercury (mmHg)
Standard Deviation 4.3
|
|
Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
Change from Baseline at Week 12
|
-3.7 Millimeters of Mercury (mmHg)
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Intent to Treat: all patients who were consented and completed the Baseline visit
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).
Outcome measures
| Measure |
Bimatoprost 0.01%
n=165 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
Baseline
|
20.8 Millimeters of Mercury (mmHg)
Standard Deviation 5.2
|
|
Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
Change from Baseline at Week 6
|
-3.8 Millimeters of Mercury (mmHg)
Standard Deviation 4.7
|
|
Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
Change from Baseline at Week 12
|
-3.7 Millimeters of Mercury (mmHg)
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Intent to Treat: all patients who were consented and completed the Baseline visit
Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.
Outcome measures
| Measure |
Bimatoprost 0.01%
n=1137 Participants
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Percentage of Patients Discontinuing Due to Ocular Adverse Events
|
3.9 Percentage of Patients
|
Adverse Events
Bimatoprost 0.01%
Serious adverse events
| Measure |
Bimatoprost 0.01%
n=1137 participants at risk
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
|
|---|---|
|
Cardiac disorders
Cerebrovascular Accident
|
0.09%
1/1137
|
|
General disorders
Malaise
|
0.09%
1/1137
|
|
Cardiac disorders
Myocardial Infarction
|
0.09%
1/1137
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER