Trial Outcomes & Findings for Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction (NCT NCT01547598)
NCT ID: NCT01547598
Last Updated: 2014-08-15
Results Overview
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
COMPLETED
PHASE4
135 participants
Week 12
2014-08-15
Participant Flow
Participant milestones
| Measure |
LUMIGAN® RC
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
|
DuoTrav®
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
68
|
|
Overall Study
COMPLETED
|
61
|
63
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
LUMIGAN® RC
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
|
DuoTrav®
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrew consent
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Other Miscellaneous Reasons
|
2
|
1
|
Baseline Characteristics
Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
Baseline characteristics by cohort
| Measure |
LUMIGAN® RC
n=67 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
|
DuoTrav®
n=68 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
65.2 Years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
66.2 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Participants from the modified Intent-to-treat (mITT) population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Outcome measures
| Measure |
LUMIGAN® RC
n=61 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
|
DuoTrav®
n=63 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
|
|---|---|---|
|
Mean Diurnal Intraocular Pressure (IOP)
|
18.6 mmHg
Standard Deviation 3.5
|
17.4 mmHg
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
LUMIGAN® RC
n=66 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
|
DuoTrav®
n=68 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean IOP at Week 12
Baseline_8 AM
|
22.0 mmHg
Standard Deviation 2.9
|
22.0 mmHg
Standard Deviation 4.1
|
|
Change From Baseline in Mean IOP at Week 12
Change from Baseline at Week 12 _8 AM (n=61,63)
|
-2.7 mmHg
Standard Deviation 3.4
|
-4.5 mmHg
Standard Deviation 3.1
|
|
Change From Baseline in Mean IOP at Week 12
Baseline_12 Noon
|
20.6 mmHg
Standard Deviation 3.2
|
20.3 mmHg
Standard Deviation 3.8
|
|
Change From Baseline in Mean IOP at Week 12
Change from Baseline at Week 12_12 Noon (n=61,63)
|
-1.9 mmHg
Standard Deviation 3.1
|
-2.3 mmHg
Standard Deviation 3.2
|
|
Change From Baseline in Mean IOP at Week 12
Baseline_4 PM
|
19.8 mmHg
Standard Deviation 3.1
|
19.8 mmHg
Standard Deviation 4.1
|
|
Change From Baseline in Mean IOP at Week 12
Change from Baseline at Week 12_4 PM (n=61,63)
|
-1.3 mmHg
Standard Deviation 2.7
|
-2.4 mmHg
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.
IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Outcome measures
| Measure |
LUMIGAN® RC
n=61 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
|
DuoTrav®
n=63 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
|
26.2 percentage of participants
|
47.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.
IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Outcome measures
| Measure |
LUMIGAN® RC
n=61 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
|
DuoTrav®
n=63 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
|
11.5 percentage of participants
|
17.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
LUMIGAN® RC
n=66 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
|
DuoTrav®
n=68 Participants
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean IOP at Week 6
Baseline_4 PM
|
19.8 mmHg
Standard Deviation 3.1
|
19.8 mmHg
Standard Deviation 4.1
|
|
Change From Baseline in Mean IOP at Week 6
Baseline_ 8 AM
|
22.0 mmHg
Standard Deviation 2.9
|
22.0 mmHg
Standard Deviation 4.1
|
|
Change From Baseline in Mean IOP at Week 6
Change from Baseline at Week 6 _8 AM (n=66,64)
|
-2.8 mmHg
Standard Deviation 2.9
|
-4.8 mmHg
Standard Deviation 4.1
|
|
Change From Baseline in Mean IOP at Week 6
Baseline_12 Noon
|
20.6 mmHg
Standard Deviation 3.2
|
20.3 mmHg
Standard Deviation 3.8
|
|
Change From Baseline in Mean IOP at Week 6
Change from Baseline at Week 6_12 Noon (n=66,64)
|
-2.1 mmHg
Standard Deviation 3.1
|
-2.8 mmHg
Standard Deviation 3.4
|
|
Change From Baseline in Mean IOP at Week 6
Change from Baseline at Week 6_4 PM (n=66,64)
|
-1.5 mmHg
Standard Deviation 2.5
|
-2.9 mmHg
Standard Deviation 3.6
|
Adverse Events
Travatan® Z
LUMIGAN® RC
DuoTrav®
Serious adverse events
| Measure |
Travatan® Z
n=135 participants at risk
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks for all participants.
|
LUMIGAN® RC
n=67 participants at risk
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
|
DuoTrav®
n=68 participants at risk
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/135
|
0.00%
0/67
|
1.5%
1/68
|
|
Infections and infestations
Cellulitis
|
0.00%
0/135
|
0.00%
0/67
|
1.5%
1/68
|
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