Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta blockers treated as per standard of care in clinical practice.
Interventions
DRUGbrimonidine tartrate/timolol maleate Ophthalmic Solution
brimonidine tartrate/timolol maleate (Combigan®) Ophthalmic Solution as per local standard of care in clinical practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution as standard of care in clinical practice.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Adverse Events | Up to 2.6 Years | An adverse event was 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. |
| Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP) | Baseline, Week 4 | IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combigan® Ophthalmic Solution Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice. | 732 |
| Total | 732 |
Baseline characteristics
| Characteristic | Combigan® Ophthalmic Solution |
|---|---|
| Age, Customized 50 - 59 years | 144 Participants |
| Age, Customized < 50 years | 140 Participants |
| Age, Customized 60 - 69 years | 219 Participants |
| Age, Customized ≥ 70 years | 225 Participants |
| Age, Customized Missing Data | 4 Participants |
| Sex/Gender, Customized Female | 347 Participants |
| Sex/Gender, Customized Male | 384 Participants |
| Sex/Gender, Customized Missing Data | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 732 |
| serious Total, serious adverse events | 0 / 732 |
Outcome results
Primary
Percentage of Participants Reporting Adverse Events
An adverse event was 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: Up to 2.6 Years
Population: Safety Population included all participants who received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combigan® Ophthalmic Solution | Percentage of Participants Reporting Adverse Events | 6.56 Percentage of participants |
Primary
Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported.
Time frame: Baseline, Week 4
Population: Efficacy Population included all participants who received study drug for \> 4 weeks and had overall assessment data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combigan® Ophthalmic Solution | Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP) | 85.69 Percentage of participants |