Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).
Interventions
1 drop in the affected eye(s), administered in the evening for 12 weeks.
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Week 12 | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | Baseline, Week 6, Week 12 | IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). |
| Overall Percent Change From Baseline in IOP | Baseline, Week 6, Week 12 | IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hyperemia Severity in the Study Eye | Baseline, Week 12 | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. | 295 |
| Bimatoprost 0.01% (Switched Monotherapy) 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. | 248 |
| Bimatoprost 0.01% (With Adjunctive Therapy) 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. | 257 |
| Total | 800 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 17 | 23 | 23 |
| Overall Study | Lost to Follow-up | 54 | 54 | 37 |
| Overall Study | Non-Adverse Event Related | 4 | 5 | 6 |
Baseline characteristics
| Characteristic | Bimatoprost 0.01% (Naive Monotherapy) | Bimatoprost 0.01% (Switched Monotherapy) | Bimatoprost 0.01% (With Adjunctive Therapy) | Total |
|---|---|---|---|---|
| Age, Continuous | 58.0 Years STANDARD_DEVIATION 13.81 | 59.5 Years STANDARD_DEVIATION 13.23 | 61.2 Years STANDARD_DEVIATION 12.59 | 59.5 Years STANDARD_DEVIATION 13.3 |
| Sex: Female, Male Female | 130 Participants | 145 Participants | 105 Participants | 380 Participants |
| Sex: Female, Male Male | 165 Participants | 103 Participants | 152 Participants | 420 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 295 | 9 / 248 | 14 / 257 |
| serious Total, serious adverse events | 1 / 295 | 0 / 248 | 1 / 257 |
Outcome results
Primary
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.
Time frame: Week 12
Population: Intent to Treat: all treated subjects with data at this time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Moderate | 31 Participants |
| Bimatoprost 0.01% (Naive Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Mild | 73 Participants |
| Bimatoprost 0.01% (Naive Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | None | 40 Participants |
| Bimatoprost 0.01% (Naive Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Trace | 71 Participants |
| Bimatoprost 0.01% (Naive Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Severe | 5 Participants |
| Bimatoprost 0.01% (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Mild | 47 Participants |
| Bimatoprost 0.01% (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | None | 49 Participants |
| Bimatoprost 0.01% (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Trace | 54 Participants |
| Bimatoprost 0.01% (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Moderate | 11 Participants |
| Bimatoprost 0.01% (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Severe | 5 Participants |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Severe | 6 Participants |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Moderate | 30 Participants |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | None | 20 Participants |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Mild | 65 Participants |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Trace | 70 Participants |
Secondary
Change From Baseline in Intraocular Pressure (IOP)
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Time frame: Baseline, Week 6, Week 12
Population: Intent to Treat: all treated subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Week 6 (N=251, 204, 233) | -4.7 Millimeters of Mercury (mmHg) | Standard Deviation 4.5 |
| Bimatoprost 0.01% (Naive Monotherapy) | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 18.6 Millimeters of Mercury (mmHg) | Standard Deviation 5.39 |
| Bimatoprost 0.01% (Naive Monotherapy) | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Week 12 (N=220, 165, 191) | -4.3 Millimeters of Mercury (mmHg) | Standard Deviation 4.42 |
| Bimatoprost 0.01% (Switched Monotherapy) | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Week 6 (N=251, 204, 233) | -2.6 Millimeters of Mercury (mmHg) | Standard Deviation 4.43 |
| Bimatoprost 0.01% (Switched Monotherapy) | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 17.0 Millimeters of Mercury (mmHg) | Standard Deviation 5.73 |
| Bimatoprost 0.01% (Switched Monotherapy) | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Week 12 (N=220, 165, 191) | -2.8 Millimeters of Mercury (mmHg) | Standard Deviation 4.68 |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Change From Baseline in Intraocular Pressure (IOP) | Baseline | 19.3 Millimeters of Mercury (mmHg) | Standard Deviation 6.19 |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Week 12 (N=220, 165, 191) | -3.4 Millimeters of Mercury (mmHg) | Standard Deviation 6.11 |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Change From Baseline in Intraocular Pressure (IOP) | Change from Baseline at Week 6 (N=251, 204, 233) | -3.2 Millimeters of Mercury (mmHg) | Standard Deviation 5.44 |
Secondary
Overall Percent Change From Baseline in IOP
IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).
Time frame: Baseline, Week 6, Week 12
Population: Intent to Treat: all treated subjects with data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) | Overall Percent Change From Baseline in IOP | Change from Baseline at Week 6 (N=251, 204, 233) | -22.09 Percent Change | Standard Deviation 17.023 |
| Bimatoprost 0.01% (Naive Monotherapy) | Overall Percent Change From Baseline in IOP | Change from Baseline at Week 12 (N=220, 165, 191) | -20.22 Percent Change | Standard Deviation 17.566 |
| Bimatoprost 0.01% (Switched Monotherapy) | Overall Percent Change From Baseline in IOP | Change from Baseline at Week 6 (N=251, 204, 233) | -12.90 Percent Change | Standard Deviation 18.912 |
| Bimatoprost 0.01% (Switched Monotherapy) | Overall Percent Change From Baseline in IOP | Change from Baseline at Week 12 (N=220, 165, 191) | -12.81 Percent Change | Standard Deviation 19.438 |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Overall Percent Change From Baseline in IOP | Change from Baseline at Week 6 (N=251, 204, 233) | -14.37 Percent Change | Standard Deviation 20.883 |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Overall Percent Change From Baseline in IOP | Change from Baseline at Week 12 (N=220, 165, 191) | -14.25 Percent Change | Standard Deviation 23.376 |
Other Pre-specified
Change From Baseline in Hyperemia Severity in the Study Eye
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented.
Time frame: Baseline, Week 12
Population: Intent to Treat: all treated subjects with data at this time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) | Change From Baseline in Hyperemia Severity in the Study Eye | No Change | 191 Participants |
| Bimatoprost 0.01% (Naive Monotherapy) | Change From Baseline in Hyperemia Severity in the Study Eye | Improved | 1 Participants |
| Bimatoprost 0.01% (Naive Monotherapy) | Change From Baseline in Hyperemia Severity in the Study Eye | Worsened | 28 Participants |
| Bimatoprost 0.01% (Switched Monotherapy) | Change From Baseline in Hyperemia Severity in the Study Eye | No Change | 149 Participants |
| Bimatoprost 0.01% (Switched Monotherapy) | Change From Baseline in Hyperemia Severity in the Study Eye | Improved | 8 Participants |
| Bimatoprost 0.01% (Switched Monotherapy) | Change From Baseline in Hyperemia Severity in the Study Eye | Worsened | 9 Participants |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Change From Baseline in Hyperemia Severity in the Study Eye | Improved | 15 Participants |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Change From Baseline in Hyperemia Severity in the Study Eye | Worsened | 17 Participants |
| Bimatoprost 0.01% (With Adjunctive Therapy) | Change From Baseline in Hyperemia Severity in the Study Eye | No Change | 159 Participants |