Open-Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Open-Angle Glaucoma, Ocular Hypertension, Simbrinza™, Intraocular Pressure
Brief summary
The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.
Detailed description
This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.
Interventions
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes. * Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments. * Must sign an Informed Consent form. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control. * Severe central visual field loss in either eye. * Chronic, recurrent or severe inflammatory eye disease. * Ocular trauma or ocular surgery within the past 6 months. * Ocular infection or ocular inflammation within the past 3 months. * Clinically significant or progressive retinal disease. * Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication. * Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study. * Any medical condition that would preclude the safe administration of a topical beta-blocker. * Cannot safely discontinue all glucocorticoids administered by any route. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Nocturnal IOP at Week 4 | Week 4: 10PM, 12AM, 2AM, 4AM, 6AM | Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diurnal IOP at Week 4 | Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM | Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). |
| Mean 24-hour IOP at Week 4 | Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM | 24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). |
Participant flow
Recruitment details
Participants were recruited from 1 study center located in the US.
Pre-assignment details
Of the 89 enrolled, 3 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (86).
Participants by arm
| Arm | Count |
|---|---|
| Simbrinza 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks | 44 |
| Timolol 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks | 42 |
| Total | 86 |
Baseline characteristics
| Characteristic | Simbrinza | Timolol | Total |
|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 10.73 | 59.7 years STANDARD_DEVIATION 11.14 | 60.1 years STANDARD_DEVIATION 10.87 |
| Sex: Female, Male Female | 24 Participants | 27 Participants | 51 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 42 |
| serious Total, serious adverse events | 0 / 44 | 0 / 42 |
Outcome results
Primary
Mean Nocturnal IOP at Week 4
Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time frame: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM
Population: This analysis population includes all participants who received study medication and had at least one on-therapy study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simbrinza | Mean Nocturnal IOP at Week 4 | Baseline (Day 0) | 24.2 mmHg | Standard Deviation 4.01 |
| Simbrinza | Mean Nocturnal IOP at Week 4 | Week 4 | 18.6 mmHg | Standard Deviation 3.61 |
| Timolol | Mean Nocturnal IOP at Week 4 | Baseline (Day 0) | 23.6 mmHg | Standard Deviation 3.31 |
| Timolol | Mean Nocturnal IOP at Week 4 | Week 4 | 18.9 mmHg | Standard Deviation 2.93 |
Secondary
Mean 24-hour IOP at Week 4
24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time frame: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM
Population: This analysis population includes all participants who received study medication and had at least one on-therapy study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simbrinza | Mean 24-hour IOP at Week 4 | Baseline (Day 0) | 23.6 mmHg | Standard Deviation 3.3 |
| Simbrinza | Mean 24-hour IOP at Week 4 | Week 4 | 17.9 mmHg | Standard Deviation 3.06 |
| Timolol | Mean 24-hour IOP at Week 4 | Baseline (Day 0) | 22.8 mmHg | Standard Deviation 2.84 |
| Timolol | Mean 24-hour IOP at Week 4 | Week 4 | 18.2 mmHg | Standard Deviation 2.63 |
Secondary
Mean Diurnal IOP at Week 4
Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time frame: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM
Population: This analysis population includes all participants who received study medication and had at least one on-therapy study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simbrinza | Mean Diurnal IOP at Week 4 | Baseline (Day 0) | 23.2 mmHg | Standard Deviation 3.17 |
| Simbrinza | Mean Diurnal IOP at Week 4 | Week 4 | 17.3 mmHg | Standard Deviation 3.01 |
| Timolol | Mean Diurnal IOP at Week 4 | Baseline (Day 0) | 22.2 mmHg | Standard Deviation 2.97 |
| Timolol | Mean Diurnal IOP at Week 4 | Week 4 | 17.7 mmHg | Standard Deviation 2.9 |