An observational study in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2014-04-04.
Sponsored by Allergan · Observational
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.
649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.
This study's enrollment of 732 is above the median of 142 across 98 observational studies indexed under Ocular Hypertension.
Browse Ocular Hypertension studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution in Clinical practice.
Exclusion Criteria:
Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution
brimonidine tartrate/timolol maleate (Combigan®) Ophthalmic Solution as per local standard of care in clinical practice.
Also known as: Combigan®
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
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
| Milestone | Combigan® Ophthalmic Solution |
|---|---|
| Started | 732 |
| Completed | 732 |
| Not completed | 0 |
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 | Combigan® Ophthalmic Solution |
|---|---|
| Percentage of Participants Reporting Adverse Events | 6.56 |
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.
| Percentage of participants | Combigan® Ophthalmic Solution |
|---|---|
| Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP) | 85.69 |
Collected over Adverse Events were assessed for up to 2.6 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combigan® Ophthalmic Solution | — | 0/732 (0%) | 0/732 (0%) |
| Age, Customized(Participants) | Combigan® Ophthalmic Solution |
|---|---|
| < 50 years | 140 |
| 50 - 59 years | 144 |
| 60 - 69 years | 219 |
| ≥ 70 years | 225 |
| Missing Data | 4 |
| Sex/Gender, Customized(Participants) | Combigan® Ophthalmic Solution |
|---|---|
| Female | 347 |
| Male | 384 |
| Missing Data | 1 |
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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