Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.
Interventions
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
DRUGtravoprost 0.004% / timolol 0.5% combination ophthalmic solution
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.
LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open angle glaucoma or ocular hypertension * Best corrected visual acuity of 20/100 or better in both eyes
Exclusion criteria
* Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks * Previous treatment with LUMIGAN® RC or DuoTrav® * History of LASIK, LASEK, RK or PRK in the study eye(s) * Active ocular inflammation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diurnal Intraocular Pressure (IOP) | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean IOP at Week 12 | Baseline, Week 12 | 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. |
| Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline | Baseline, Week 12 | 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. |
| Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg | Week 12 | 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. |
| Change From Baseline in Mean IOP at Week 6 | Baseline, Week 6 | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 67 |
| 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. | 68 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Other Miscellaneous Reasons | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrew consent | 1 | 1 |
Baseline characteristics
| Characteristic | LUMIGAN® RC | DuoTrav® | Total |
|---|---|---|---|
| Age, Continuous | 67.2 Years STANDARD_DEVIATION 9.7 | 65.2 Years STANDARD_DEVIATION 10.7 | 66.2 Years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 27 Participants | 28 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 135 | 0 / 67 | 0 / 68 |
| serious Total, serious adverse events | 0 / 135 | 0 / 67 | 1 / 68 |
Outcome results
Primary
Mean Diurnal Intraocular Pressure (IOP)
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LUMIGAN® RC | Mean Diurnal Intraocular Pressure (IOP) | 18.6 mmHg | Standard Deviation 3.5 |
| DuoTrav® | Mean Diurnal Intraocular Pressure (IOP) | 17.4 mmHg | Standard Deviation 2.7 |
Secondary
Change From Baseline in Mean IOP at Week 12
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LUMIGAN® RC | Change From Baseline in Mean IOP at Week 12 | Baseline_8 AM | 22.0 mmHg | Standard Deviation 2.9 |
| LUMIGAN® RC | 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 |
| LUMIGAN® RC | Change From Baseline in Mean IOP at Week 12 | Baseline_12 Noon | 20.6 mmHg | Standard Deviation 3.2 |
| LUMIGAN® RC | 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 |
| LUMIGAN® RC | Change From Baseline in Mean IOP at Week 12 | Baseline_4 PM | 19.8 mmHg | Standard Deviation 3.1 |
| LUMIGAN® RC | 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 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 12 | Baseline_4 PM | 19.8 mmHg | Standard Deviation 4.1 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 12 | Baseline_8 AM | 22.0 mmHg | Standard Deviation 4.1 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 12 | Change from Baseline at Week 12_12 Noon (n=61,63) | -2.3 mmHg | Standard Deviation 3.2 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 12 | Change from Baseline at Week 12 _8 AM (n=61,63) | -4.5 mmHg | Standard Deviation 3.1 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 12 | Change from Baseline at Week 12_4 PM (n=61,63) | -2.4 mmHg | Standard Deviation 3.5 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 12 | Baseline_12 Noon | 20.3 mmHg | Standard Deviation 3.8 |
Secondary
Change From Baseline in Mean IOP at Week 6
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.
Time frame: Baseline, Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LUMIGAN® RC | Change From Baseline in Mean IOP at Week 6 | Baseline_ 8 AM | 22.0 mmHg | Standard Deviation 2.9 |
| LUMIGAN® RC | 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 |
| LUMIGAN® RC | Change From Baseline in Mean IOP at Week 6 | Baseline_12 Noon | 20.6 mmHg | Standard Deviation 3.2 |
| LUMIGAN® RC | 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 |
| LUMIGAN® RC | Change From Baseline in Mean IOP at Week 6 | Baseline_4 PM | 19.8 mmHg | Standard Deviation 3.1 |
| LUMIGAN® RC | 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 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 6 | Baseline_4 PM | 19.8 mmHg | Standard Deviation 4.1 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 6 | Baseline_ 8 AM | 22.0 mmHg | Standard Deviation 4.1 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 6 | Change from Baseline at Week 6_12 Noon (n=66,64) | -2.8 mmHg | Standard Deviation 3.4 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 6 | Change from Baseline at Week 6 _8 AM (n=66,64) | -4.8 mmHg | Standard Deviation 4.1 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 6 | Change from Baseline at Week 6_4 PM (n=66,64) | -2.9 mmHg | Standard Deviation 3.6 |
| DuoTrav® | Change From Baseline in Mean IOP at Week 6 | Baseline_12 Noon | 20.3 mmHg | Standard Deviation 3.8 |
Secondary
Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LUMIGAN® RC | Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline | 26.2 percentage of participants |
| DuoTrav® | Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline | 47.6 percentage of participants |
Secondary
Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LUMIGAN® RC | Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg | 11.5 percentage of participants |
| DuoTrav® | Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg | 17.5 percentage of participants |