Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.
Interventions
DRUGbimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Glaucoma and/or ocular hypertension in both eyes * Requires IOP-lowering treatment in both eyes
Exclusion criteria
* Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye) * Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears * Use of oral, injectable or topical corticosteroids within 21 days * Iridectomy or laser peripheral iridotomy in the study eye within 3 months * Uncomplicated cataract surgery in the study eye within 6 months * Incisional glaucoma surgery in the study eye within 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye | Baseline, Week 12 | IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening). |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Triple Combination Therapy One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks. | 126 |
| Total | 126 |
Baseline characteristics
| Characteristic | Triple Combination Therapy |
|---|---|
| Age, Customized 45 to 65 years | 84 Participants |
| Age, Customized <45 years | 11 Participants |
| Age, Customized >65 years | 31 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 121 |
| serious Total, serious adverse events | 0 / 121 |
Outcome results
Primary
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Time frame: Baseline, Week 12
Population: Modified Intent to Treat: includes all qualified patients with a baseline and at least 1 postbaseline efficacy evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triple Combination Therapy | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye | Baseline | 22.35 Millimeters of Mercury (mmHg) | Standard Deviation 3.417 |
| Triple Combination Therapy | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye | Change from Baseline at Week 12 | -3.98 Millimeters of Mercury (mmHg) | Standard Deviation 2.856 |