Glaucoma, Primary Open Angle, Ocular Hypertension
Conditions
Brief summary
This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).
Interventions
One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary open-angle glaucoma or ocular hypertension * Determined by the treating physician to require treatment with bimatoprost 0.01%.
Exclusion criteria
* Previous use of Lumigan® 0.01%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | 12 Weeks | 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 patients in each severity grade are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline, 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) and a positive number change from baseline indicates an increase in IOP (worsening). |
| Percentage of Patients Who Discontinue Due to an Adverse Event | 12 Weeks | An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. |
| Overall Percent Change From Baseline in IOP | Baseline, Week 12 | IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening). |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pts With POAG or OH (Previously Treatment Naive) Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). | 42 |
| Pts With POAG or OH (Switched Monotherapy) Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). | 270 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 5 |
| Overall Study | Ocular Adverse Event | 6 | 15 |
| Overall Study | Other Reasons | 1 | 10 |
Baseline characteristics
| Characteristic | Pts With POAG or OH (Previously Treatment Naive) | Pts With POAG or OH (Switched Monotherapy) | Total |
|---|---|---|---|
| Age, Continuous | 52.5 Years STANDARD_DEVIATION 13.65 | 53.4 Years STANDARD_DEVIATION 14.45 | 53.3 Years STANDARD_DEVIATION 14.33 |
| Sex: Female, Male Female | 20 Participants | 114 Participants | 134 Participants |
| Sex: Female, Male Male | 22 Participants | 156 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 42 | 16 / 270 |
| serious Total, serious adverse events | 1 / 42 | 2 / 270 |
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 patients in each severity grade are presented.
Time frame: 12 Weeks
Population: Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pts With POAG or OH (Previously Treatment Naive) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Moderate | 5 Patients |
| Pts With POAG or OH (Previously Treatment Naive) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Severe | 0 Patients |
| Pts With POAG or OH (Previously Treatment Naive) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | None | 7 Patients |
| Pts With POAG or OH (Previously Treatment Naive) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Trace | 10 Patients |
| Pts With POAG or OH (Previously Treatment Naive) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Mild | 12 Patients |
| Pts With POAG or OH (Previously Treatment Naive) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Missing | 8 Patients |
| Pts With POAG or OH (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Mild | 84 Patients |
| Pts With POAG or OH (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Moderate | 59 Patients |
| Pts With POAG or OH (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Trace | 50 Patients |
| Pts With POAG or OH (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Severe | 11 Patients |
| Pts With POAG or OH (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Missing | 30 Patients |
| Pts With POAG or OH (Switched Monotherapy) | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | None | 36 Patients |
Secondary
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
Time frame: Baseline, Week 12
Population: Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pts With POAG or OH (Previously Treatment Naive) | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Week 12 (N=34, 240) | -3.6 Millimeters of Mercury (mmHg) | Standard Deviation 3.55 |
| Pts With POAG or OH (Previously Treatment Naive) | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline | 18.0 Millimeters of Mercury (mmHg) | Standard Deviation 3.82 |
| Pts With POAG or OH (Switched Monotherapy) | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline | 17.8 Millimeters of Mercury (mmHg) | Standard Deviation 3.89 |
| Pts With POAG or OH (Switched Monotherapy) | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Week 12 (N=34, 240) | -2.6 Millimeters of Mercury (mmHg) | Standard Deviation 3.22 |
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) and a positive number change response indicates an increase in IOP (worsening).
Time frame: Baseline, Week 12
Population: Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pts With POAG or OH (Previously Treatment Naive) | Overall Percent Change From Baseline in IOP | -19.25 Percentage Change |
| Pts With POAG or OH (Switched Monotherapy) | Overall Percent Change From Baseline in IOP | -13.26 Percentage Change |
Secondary
Percentage of Patients Who Discontinue Due to an Adverse Event
An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.
Time frame: 12 Weeks
Population: Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pts With POAG or OH (Previously Treatment Naive) | Percentage of Patients Who Discontinue Due to an Adverse Event | 14.3 Percentage of Patients |
| Pts With POAG or OH (Switched Monotherapy) | Percentage of Patients Who Discontinue Due to an Adverse Event | 5.6 Percentage of Patients |