Ocular Hypertension Clinical Trial
Official title:
Comparison of the Effects of Latanoprost(0.005%) and Brinzolamide(1.0%) on Intraocular Pressure in Primary Open-angle Glaucoma and Ocular Hypertension
Prostaglandin analogs (PGAs) represent a new class of active ocular hypotensive agents and
possess a unique mechanism of action. Many studies suggested that 0.005% Latanoprost was
more effective and safer than other anti-glaucoma medications, such as beta-blockers. It has
also been found to be more effective than other class of anti-glaucoma medications such as
carbonic anhydrase inhibitors and alpha agonists. However data on such comparison is lacking
in Chinese patients. So it is necessary to increase China experience and get clinical data
from China. Besides latanoprost, brinzolamide is known as one of the other ocular
hypotensive agents with less systemic adverse effects, therefore it is selected as the
controlled medication of this study. The administration phase will be 4 weeks because it is
long enough to compare both efficacy and safety of the study drugs and accounting for
following-up conditions in China, it will be easier for the investigators to get enough
subjects in a limited stage if the observation time is shorter.
Before treatment with the study drugs, any previous glaucoma drugs will be washed out. The
minimum washout periods are 5 days for cholinergic agonists, 1 week for adrenergic agonists,
3 weeks for adrenergic β receptor blockers and 4 weeks for PGAS. After washout, the patients
will be randomised send to two parallel study groups: one group will receive latanoprost
0.005% once daily in the evening, the other group receive 1.0% Brinzolamide twice daily.
Randomization will be obtained using a list of random numbers .During the study there will
be four visits: screening, baseline, 2 weeks, and 4 weeks of treatment. The IOP will be
measured with a Goldmann tonometer at 8 am for each visit. The tonometry will be performed
before the administration of the dose of the day in patients treated with Brinzolamide.
Three separate measurements will be taken for each eye and the mean of the three
measurements will be used in the statistical analysis. Best corrected visual acuity and
refraction will be determined and a slit lamp examination, ophthalmoscopy will be performed
at all visits.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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