Glaucoma
Conditions
Brief summary
The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.
Detailed description
Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.
Interventions
DRUGVehicle
Inactive ingredients used as a placebo for masking purposes
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of either open-angle glaucoma or ocular hypertension; * Able to attend all study related visits and be housed overnight at clinical site for the study assessments; * Willing and able to sign an informed consent form; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control; * Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension; * Ocular surgeries or procedures excluded by the protocol; * Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol; * Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye; * Other protocol-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 | Baseline (Day 0), Week 4 | IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Change From Baseline in Daytime IOP at Week 4 | Baseline (Day 0), Week 4 | IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. |
| Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4 | Baseline (Day 0), Week 4 | IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. |
| Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | Baseline (Day 0), Week 4 | IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 16 study centers located in the United States.
Pre-assignment details
Of the 162 enrolled, 37 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (125).
Participants by arm
| Arm | Count |
|---|---|
| SIMBRINZA Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days | 62 |
| Vehicle Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days | 61 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Randomized in error, prior to treatment | 0 | 1 |
Baseline characteristics
| Characteristic | SIMBRINZA | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 8.52 | 63.6 years STANDARD_DEVIATION 11.22 | 65.5 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 38 Participants | 41 Participants | 79 Participants |
| Sex: Female, Male Male | 24 Participants | 20 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 60 |
| other Total, other adverse events | 0 / 64 | 4 / 60 |
| serious Total, serious adverse events | 0 / 64 | 2 / 60 |
Outcome results
Primary
Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4
IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Week 4
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SIMBRINZA | Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 | -3.09 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 | -0.60 mmHg |
Secondary
Least Squares Mean Change From Baseline in Daytime IOP at Week 4
IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Week 4
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SIMBRINZA | Least Squares Mean Change From Baseline in Daytime IOP at Week 4 | -3.93 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in Daytime IOP at Week 4 | -0.51 mmHg |
Secondary
Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4
IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Week 4
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 8AM | -3.28 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 10AM | -5.05 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 12PM | -4.03 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 2PM | -3.36 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 4PM | -3.95 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 6PM | -4.46 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 8PM | -3.42 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 10PM | -2.10 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 12AM | -1.79 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 2AM | -2.30 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 4AM | -1.42 mmHg |
| SIMBRINZA | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 6AM | -1.95 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 4AM | -0.98 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 8AM | -0.49 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 8PM | -0.72 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 10AM | -0.61 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 2AM | -0.55 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 12PM | -0.27 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 10PM | -0.67 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 2PM | -0.66 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 6AM | -0.63 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 4PM | -0.51 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 12AM | -0.83 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 | 6PM | -0.32 mmHg |
Secondary
Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4
IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Week 4
Population: Full Analysis Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SIMBRINZA | Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4 | -1.88 mmHg |
| Vehicle | Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4 | -0.73 mmHg |