Ocular Hypertension, Open-angle Glaucoma
Conditions
Brief summary
This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension
Interventions
DRUG0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution
One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
DRUG0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes * Eye pressure lowering topical medications are not working * Visual acuity is at least 0.2 in each eye
Exclusion criteria
* Uncontrolled systemic disease * Any other active eye disease other than glaucoma or ocular hypertension * Significant visual field loss or evidence of progressive visual field loss within the last year * Anticipated wearing of contact lenses during the study * Required chronic use of other ocular medications during the study * Eye surgery or laser treatment within 12 weeks prior to study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | Baseline, Week 4 | The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.03% Bimatoprost/0.5% Timolol in Same Bottle Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution | 121 |
| 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution | 114 |
| Total | 235 |
Baseline characteristics
| Characteristic | Total | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles |
|---|---|---|---|
| Age, Continuous | 45.02 years STANDARD_DEVIATION 15.51 | 45.73 years STANDARD_DEVIATION 14.77 | 44.28 years STANDARD_DEVIATION 16.28 |
| Sex: Female, Male Female | 92 Participants | 46 Participants | 46 Participants |
| Sex: Female, Male Male | 143 Participants | 75 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 121 | 29 / 114 |
| serious Total, serious adverse events | 0 / 121 | 2 / 114 |
Outcome results
Primary
The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4
The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.
Time frame: Baseline, Week 4
Population: Intent to Treatment population defined as all patients randomized. One patient in the 0.03% Bimatoprost/0.5% Timolol in Same Bottle group was not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.03% Bimatoprost/0.5% Timolol in Same Bottle | The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | Baseline | 25.20 Millimeters of mercury (mmHg) | Standard Deviation 3.06 |
| 0.03% Bimatoprost/0.5% Timolol in Same Bottle | The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | Change from Baseline at Week 4 | -9.38 Millimeters of mercury (mmHg) | Standard Deviation 4.66 |
| 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | Baseline | 24.87 Millimeters of mercury (mmHg) | Standard Deviation 3.88 |
| 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | Change from Baseline at Week 4 | -8.93 Millimeters of mercury (mmHg) | Standard Deviation 4.25 |
Comparison: A non-inferiority test was performed for comparing the change from baseline in mean diurnal IOP at Week 4 between treatment groups. The null hypothesis was that the mean diurnal IOP change at Week 4 for Group 1 was at least 1.5 mmHg greater than that for Group 2. The hypothesis was tested using a confidence interval approach based on a 2-way analysis of variance (ANOVA) model including factors for treatment and investigator.95% CI: [-1.68, 0.57]