Glaucoma, Ocular Hypertension
Conditions
Brief summary
A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects
Interventions
1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day
1 drop of study medication taken once daily
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
1. Be at least 18 years of age; 2. Give written informed consent; 3. Be in good general health as determined by your doctor; 4. Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension; 5. If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills); 6. Understand the study instructions, and be able to follow the study instructions; and 7. Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.
Exclusion criteria
1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation; 2. Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and 3. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) at Week 12 | Week 12 | Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution | 73 |
| Latanoprost 0.005% Ophthalmic Solution Latanoprost 0.005% ophthalmic solution | 75 |
| Total | 148 |
Baseline characteristics
| Characteristic | Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate | Latanoprost 0.005% Ophthalmic Solution | Total |
|---|---|---|---|
| Age Continuous | 65 years | 65 years | 65 years |
| Sex: Female, Male Female | 42 Participants | 44 Participants | 86 Participants |
| Sex: Female, Male Male | 31 Participants | 31 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 73 | 0 / 75 |
| serious Total, serious adverse events | 0 / 73 | 1 / 75 |
Outcome results
Primary
Intraocular Pressure (IOP) at Week 12
Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.
Time frame: Week 12
Population: Intent-to-treat, which included all patients who started the study (randomized).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate | Intraocular Pressure (IOP) at Week 12 | 17.75 Millimeters of mercury (mm Hg) | Standard Deviation 2.878 |
| Latanoprost 0.005% Ophthalmic Solution | Intraocular Pressure (IOP) at Week 12 | 17.90 Millimeters of mercury (mm Hg) | Standard Deviation 3.943 |