Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.
Interventions
DRUGbrimonidine tartrate/timolol fixed combination ophthalmic solution
One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
OTHERfixed combination vehicle
Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers * No anticipated wearing of contact lenses during study
Exclusion criteria
* Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye) * Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months * Required regular use of other ocular medications except for occasional use of artificial tears
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Baseline, Week 4 | Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combigan® One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. | 120 |
| Alphagan® and Timolol Concurrent One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. | 118 |
| Total | 238 |
Baseline characteristics
| Characteristic | Combigan® | Alphagan® and Timolol Concurrent | Total |
|---|---|---|---|
| Age Continuous | 46.2 Years STANDARD_DEVIATION 15.18 | 48.2 Years STANDARD_DEVIATION 15.57 | 47.2 Years STANDARD_DEVIATION 15.38 |
| Sex: Female, Male Female | 48 Participants | 55 Participants | 103 Participants |
| Sex: Female, Male Male | 72 Participants | 63 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 120 | 0 / 116 |
| serious Total, serious adverse events | 1 / 120 | 1 / 116 |
Outcome results
Primary
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Time frame: Baseline, Week 4
Population: Intent-to-treat population consisted of all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combigan® | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Baseline | 25.07 mm Hg | Standard Deviation 3.737 |
| Combigan® | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Change from baseline at Week 4 | -6.21 mm Hg | Standard Deviation 3.55 |
| Alphagan® and Timolol Concurrent | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Baseline | 24.53 mm Hg | Standard Deviation 2.926 |
| Alphagan® and Timolol Concurrent | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Change from baseline at Week 4 | -5.70 mm Hg | Standard Deviation 3.469 |