Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular hypertension in Korea.
Interventions
DRUGbimatoprost/timolol
Bimatoprost/timolol (Ganfort®) treatment for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients treated with Ganfort® for open-angle glaucoma or ocular hypertension in clinical practice.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events and Adverse Drug Reactions | Up to 51 months | An Adverse Event was considered 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. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | Baseline, Week 4 | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ganfort® Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice. | 742 |
| Total | 742 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Participants age less than 19 years | 12 |
| Overall Study | Participants contraindicated | 2 |
Baseline characteristics
| Characteristic | Ganfort® |
|---|---|
| Age, Customized 18 to <30 years | 23 participants |
| Age, Customized 30 to 39 years | 67 participants |
| Age, Customized 40 to 49 years | 91 participants |
| Age, Customized 50 to 59 years | 167 participants |
| Age, Customized 60 to 69 years | 196 participants |
| Age, Customized 70 to 79 years | 151 participants |
| Age, Customized ≥80 years | 46 participants |
| Age, Customized Data not Available | 1 participants |
| Sex: Female, Male Female | 316 Participants |
| Sex: Female, Male Male | 426 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 86 / 742 |
| serious Total, serious adverse events | 1 / 742 |
Outcome results
Primary
Number of Participants With Adverse Events and Adverse Drug Reactions
An Adverse Event was considered 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. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
Time frame: Up to 51 months
Population: Safety population included all participants treated for on-label indications.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ganfort® | Number of Participants With Adverse Events and Adverse Drug Reactions | Adverse Events | 146 participants |
| Ganfort® | Number of Participants With Adverse Events and Adverse Drug Reactions | Adverse Drug Reactions | 134 participants |
Secondary
Change From Baseline in Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days.
Time frame: Baseline, Week 4
Population: Efficacy population included all participants who were treated for on-label indications with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ganfort® | Change From Baseline in Intraocular Pressure (IOP) | Right Eye: Baseline (n=608) | 18.23 mmHg | Standard Deviation 6.69 |
| Ganfort® | Change From Baseline in Intraocular Pressure (IOP) | Right Eye: Change from Baseline (n=608) | -3.28 mmHg | Standard Deviation 5.32 |
| Ganfort® | Change From Baseline in Intraocular Pressure (IOP) | Left Eye: Baseline (n=616) | 18.23 mmHg | Standard Deviation 6.48 |
| Ganfort® | Change From Baseline in Intraocular Pressure (IOP) | Left Eye: Change from Baseline (n=616) | -3.50 mmHg | Standard Deviation 5.24 |