Ocular Hypertension Clinical Trial
Verified date | February 2014 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | 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.
Status | Completed |
Enrollment | 732 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution as standard of care in clinical practice. Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Up to 2.6 Years | No |
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. | Baseline, Week 4 | No |
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