Glaucoma, Ocular Hypertension
Conditions
Brief summary
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.
Interventions
DRUGFixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%
1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
1 drop of latanoprost 0.005% once nightly.
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
* Be at least 18 years of age * Give written informed consent * Be in good general health as determined by your doctor * Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension * 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) * Understand the study instructions, and be able to follow the study instructions; and * Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits
Exclusion criteria
* Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation * History of severe renal or hepatic impairment * Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist * Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure * 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 * 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 |
|---|---|---|
| Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | Week 12 | Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | Week 6 | Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. |
| Mean Intraocular Pressure (IOP) at 8 AM at Week 12 | Week 12 | Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye. |
| Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | Week 6 | Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. |
| Number of Subjects With Adverse Events | Week 12 | Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit). |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combigan® Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%) | 102 |
| Timolol Maleate 0.5% Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%) | 102 |
| Total | 204 |
Baseline characteristics
| Characteristic | Combigan® | Timolol Maleate 0.5% | Total |
|---|---|---|---|
| Age, Continuous | 64.5 years | 65.9 years | 65.4 years |
| Sex: Female, Male Female | 57 Participants | 45 Participants | 102 Participants |
| Sex: Female, Male Male | 45 Participants | 57 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 102 | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 | 2 / 102 |
Outcome results
Primary
Mean Intraocular Pressure (IOP) at 10 AM at Week 12
Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.
Time frame: Week 12
Population: Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combigan® | Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | 15.1 Millimeters of mercury (mmHg) | Standard Deviation 2.59 |
| Timolol Maleate 0.5% | Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | 16.9 Millimeters of mercury (mmHg) | Standard Deviation 2.46 |
Secondary
Mean Intraocular Pressure (IOP) at 10 AM at Week 6
Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.
Time frame: Week 6
Population: Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combigan® | Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | 15.9 Millimeters of mercury (mmHg) | Standard Deviation 3.1 |
| Timolol Maleate 0.5% | Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | 16.7 Millimeters of mercury (mmHg) | Standard Deviation 2.78 |
Secondary
Mean Intraocular Pressure (IOP) at 8 AM at Week 12
Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.
Time frame: Week 12
Population: Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combigan® | Mean Intraocular Pressure (IOP) at 8 AM at Week 12 | 17.0 Millimeters of mercury (mmHg) | Standard Deviation 2.55 |
| Timolol Maleate 0.5% | Mean Intraocular Pressure (IOP) at 8 AM at Week 12 | 17.7 Millimeters of mercury (mmHg) | Standard Deviation 2.58 |
Secondary
Mean Intraocular Pressure (IOP) at 8 AM at Week 6
Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.
Time frame: Week 6
Population: Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combigan® | Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | 17.3 Millimeters of mercury (mmHg) | Standard Deviation 2.87 |
| Timolol Maleate 0.5% | Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | 17.8 Millimeters of mercury (mmHg) | Standard Deviation 3.17 |
Secondary
Number of Subjects With Adverse Events
Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).
Time frame: Week 12
Population: Safety population, which included all patients who started the study (randomized) and were treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combigan® | Number of Subjects With Adverse Events | 15 Participants |
| Timolol Maleate 0.5% | Number of Subjects With Adverse Events | 13 Participants |