Al. Robin et al., SHORT-TERM EFFICACY OF APRACLONIDINE HYDROCHLORIDE ADDED TO MAXIMUM-TOLERATED MEDICAL THERAPY FOR GLAUCOMA, American journal of ophthalmology, 120(4), 1995, pp. 423-432
PURPOSE: We determined whether the addition of topical apraclonidine h
ydrochloride to eyes that are receiving maximal medical therapy but st
ill have inadequate intraocular pressure control and that are schedule
d to undergo surgery could adequately decrease intraocular pressure, p
ostponing the need for further intervention. METHODS: We performed a p
rospective, 90-day, multicentered, placebo-controlled, double-masked p
arallel study. We enrolled one eye each of 174 glaucoma patients with
inadequate intraocular pressure control who were on maximally tolerate
d medical therapy. We continued to administer maximum medical therapy
for glaucoma, Study medications were either apraclonidine hydrochlorid
e 0.5% or placebo (apraclonidine's vehicle). Patients were instructed
to take the study medication every eight hours. We measured intraocula
r pressure, change in intraocular pressure from baseline, and the numb
er of eyes requiring surgery after the addition of study medication. R
ESULTS: Fifty-two (60%) of 86 patients treated with apraclonidine main
tained adequate intraocular pressure control throughout the study and
avoided surgery, compared with 28 (32%) of 88 patients treated with pl
acebo (P < .001). Apraclonidine treatment resulted in significantly mo
re patients attaining an additional 20% reduction or more in intraocul
ar pressure from baseline and an intraocular pressure less than or equ
al to 20 mm Hg (P < .05). The most common ocular complication was conj
unctival hyperemia (11 of 86 patients, 12.8%), The most frequent nonoc
ular problem was dry mouth (four patients, 4.7%). CONCLUSION: Apraclon
idine appeared to be safe in all eyes and efficacious in some eyes. It
significantly lowered intraocular pressure when used in combination w
ith maximally tolerated medical therapy, which delayed or prevented fu
rther glaucoma surgery for at least 90 days in 52 (60%) of 86 treated
patients.