Ocular Hypertension Clinical Trial
— APPEAL-TaiwanVerified date | September 2015 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Center for Drug Evaluation |
Study type | Observational |
This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).
Status | Completed |
Enrollment | 312 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of primary open-angle glaucoma or ocular hypertension - Determined by the treating physician to require treatment with bimatoprost 0.01%. Exclusion Criteria: - Previous use of LumiganĀ® 0.01% |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented. | 12 Weeks | No |
Secondary | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | IOP is a measure 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 in IOP (worsening). | Baseline, Week 12 | No |
Secondary | Percentage of Patients Who Discontinue Due to an Adverse Event | An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. | 12 Weeks | No |
Secondary | Overall Percent Change From Baseline in IOP | IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening). | Baseline, Week 12 | No |
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