Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.
Interventions
DRUG0.03% Bimatoprost
0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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 |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline, Week 5 | IOP is a measurement 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 (worsening). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.03% Bimatoprost 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks. | 87 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 4 |
Baseline characteristics
| Characteristic | 0.03% Bimatoprost |
|---|---|
| Age, Continuous | 47.3 Years STANDARD_DEVIATION 18.1 |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 67 / 87 |
| serious Total, serious adverse events | 0 / 87 |
Outcome results
Primary
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement 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 (worsening).
Time frame: Baseline, Week 5
Population: Intent-to-Treat: all treated patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.03% Bimatoprost | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline | 22.2 Millimeters of Mercury (mmHg) | Standard Deviation 5.3 |
| 0.03% Bimatoprost | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Change from Baseline at Week 5 | -6.7 Millimeters of Mercury (mmHg) | Standard Deviation 4.5 |