Efficacy Comparison of Xalatan and Azopt on POAG and OH
Status:
Unknown status
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
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.