Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.
Interventions
Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of open-angle glaucoma or ocular hypertension * No use of Lumigan® in the past 3 months
Exclusion criteria
* Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) in the Study Eye | Month 3 | IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog \[PGA\] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With an Adverse Event of Conjunctival Hyperemia | 3 Months | Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 0.03% Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months. | 263 |
| Total | 263 |
Baseline characteristics
| Characteristic | Bimatoprost 0.03% |
|---|---|
| Age, Continuous | 48.7 Years STANDARD_DEVIATION 16.6 |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 229 / 250 |
| serious Total, serious adverse events | 0 / 250 |
Outcome results
Primary
Intraocular Pressure (IOP) in the Study Eye
IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog \[PGA\] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).
Time frame: Month 3
Population: All enrolled patients with data available for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% | Intraocular Pressure (IOP) in the Study Eye | Group A (N=89) | 16.5 Millimeters of Mercury (mmHg) | Standard Deviation 3.4 |
| Bimatoprost 0.03% | Intraocular Pressure (IOP) in the Study Eye | Group B (N=33) | 16.7 Millimeters of Mercury (mmHg) | Standard Deviation 3.3 |
| Bimatoprost 0.03% | Intraocular Pressure (IOP) in the Study Eye | Group C (N=67) | 15.7 Millimeters of Mercury (mmHg) | Standard Deviation 2.6 |
| Bimatoprost 0.03% | Intraocular Pressure (IOP) in the Study Eye | Group D (N=18) | 16.1 Millimeters of Mercury (mmHg) | Standard Deviation 3.5 |
| Bimatoprost 0.03% | Intraocular Pressure (IOP) in the Study Eye | Group E (N=33) | 17.2 Millimeters of Mercury (mmHg) | Standard Deviation 4.4 |
Secondary
Percentage of Patients With an Adverse Event of Conjunctival Hyperemia
Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Time frame: 3 Months
Population: Safety population defined as all enrolled patients who completed at least 1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost 0.03% | Percentage of Patients With an Adverse Event of Conjunctival Hyperemia | 76.0 Percentage of Patients |