Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.
Interventions
One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ocular hypertension or primary open-angle glaucoma in each eye * Requires treatment with IOP-lowering medication in both eyes
Exclusion criteria
* Required chronic use of ocular medications during the study other than study medication * Use of any corticosteroids within 30 days * History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit * Anticipated wearing of contact lenses during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline, Week 12 | IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Worse Eye IOP | Baseline, Weeks 1, 2, 4 and 8 | IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement. |
| Mean Worse Eye IOP | Weeks 1, 2, 4, 8 and 12 | IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point. |
Countries
Colombia, Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Triple Combination Therapy Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks. | 94 |
| Combigan® Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks. | 98 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 |
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Personal Reasons | 1 | 1 |
Baseline characteristics
| Characteristic | Triple Combination Therapy | Combigan® | Total |
|---|---|---|---|
| Age, Customized ≤65 years | 67 Participants | 74 Participants | 141 Participants |
| Age, Customized >65 years | 27 Participants | 24 Participants | 51 Participants |
| Sex: Female, Male Female | 78 Participants | 73 Participants | 151 Participants |
| Sex: Female, Male Male | 16 Participants | 25 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 57 / 93 | 25 / 98 |
| serious Total, serious adverse events | 3 / 93 | 0 / 98 |
Outcome results
Primary
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.
Time frame: Baseline, Week 12
Population: Participants from the modified Intent-to-treat (mITT) population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triple Combination Therapy | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline (n=93,95) | 24.62 mmHg | Standard Deviation 2.475 |
| Triple Combination Therapy | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from Baseline at Week 12 (n=93,94) | -10.03 mmHg | Standard Deviation 2.661 |
| Combigan® | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 | Baseline (n=93,95) | 25.12 mmHg | Standard Deviation 2.178 |
| Combigan® | Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from Baseline at Week 12 (n=93,94) | -9.18 mmHg | Standard Deviation 2.566 |
Secondary
Change From Baseline in Mean Worse Eye IOP
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.
Time frame: Baseline, Weeks 1, 2, 4 and 8
Population: Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triple Combination Therapy | Change From Baseline in Mean Worse Eye IOP | Change from Baseline at Week 1 (n=91,89) | -10.18 mmHg | Standard Deviation 3.149 |
| Triple Combination Therapy | Change From Baseline in Mean Worse Eye IOP | Change from Baseline at Week 4 (n=86,90) | -10.06 mmHg | Standard Deviation 2.793 |
| Triple Combination Therapy | Change From Baseline in Mean Worse Eye IOP | Change from Baseline at Week 2 (n=88,93) | -10.40 mmHg | Standard Deviation 2.802 |
| Triple Combination Therapy | Change From Baseline in Mean Worse Eye IOP | Change from Baseline at Week 8 (n=88,89) | -9.77 mmHg | Standard Deviation 2.852 |
| Triple Combination Therapy | Change From Baseline in Mean Worse Eye IOP | Baseline (n=93,95) | 24.62 mmHg | Standard Deviation 2.475 |
| Combigan® | Change From Baseline in Mean Worse Eye IOP | Change from Baseline at Week 8 (n=88,89) | -9.02 mmHg | Standard Deviation 2.869 |
| Combigan® | Change From Baseline in Mean Worse Eye IOP | Baseline (n=93,95) | 25.12 mmHg | Standard Deviation 2.178 |
| Combigan® | Change From Baseline in Mean Worse Eye IOP | Change from Baseline at Week 1 (n=91,89) | -8.90 mmHg | Standard Deviation 3.044 |
| Combigan® | Change From Baseline in Mean Worse Eye IOP | Change from Baseline at Week 2 (n=88,93) | -9.06 mmHg | Standard Deviation 2.925 |
| Combigan® | Change From Baseline in Mean Worse Eye IOP | Change from Baseline at Week 4 (n=86,90) | -9.21 mmHg | Standard Deviation 2.306 |
Secondary
Mean Worse Eye IOP
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.
Time frame: Weeks 1, 2, 4, 8 and 12
Population: Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triple Combination Therapy | Mean Worse Eye IOP | Week 12 (n=86,88) | 14.43 mmHg | Standard Deviation 2.344 |
| Triple Combination Therapy | Mean Worse Eye IOP | Week 1 (n=91,90) | 14.43 mmHg | Standard Deviation 2.785 |
| Triple Combination Therapy | Mean Worse Eye IOP | Week 2 (n=88,95) | 14.05 mmHg | Standard Deviation 2.634 |
| Triple Combination Therapy | Mean Worse Eye IOP | Week 4 (n=86,92) | 14.38 mmHg | Standard Deviation 2.587 |
| Triple Combination Therapy | Mean Worse Eye IOP | Week 8 (n=88,91) | 14.68 mmHg | Standard Deviation 2.709 |
| Combigan® | Mean Worse Eye IOP | Week 8 (n=88,91) | 16.11 mmHg | Standard Deviation 2.935 |
| Combigan® | Mean Worse Eye IOP | Week 4 (n=86,92) | 15.96 mmHg | Standard Deviation 2.705 |
| Combigan® | Mean Worse Eye IOP | Week 1 (n=91,90) | 16.23 mmHg | Standard Deviation 2.968 |
| Combigan® | Mean Worse Eye IOP | Week 12 (n=86,88) | 15.92 mmHg | Standard Deviation 2.867 |
| Combigan® | Mean Worse Eye IOP | Week 2 (n=88,95) | 16.08 mmHg | Standard Deviation 2.726 |