Short-term efficacy of apraclonidine hydrochloride added to maximum-tolerated medical therapy for glaucoma. Apraclonidine Maximum-Tolerated Medical Therapy Study Group.
OBJECTIVE
We determined whether the addition of topical apraclonidine hydrochloride to eyes that are receiving maximal medical therapy but still have inadequate intraocular pressure control and that are scheduled to undergo surgery could adequately decrease intraocular pressure, postponing the need for further intervention.


METHODS
We performed a prospective, 90-day, multicentered, placebo-controlled, double-masked parallel study. We enrolled one eye each of 174 glaucoma patients with inadequate intraocular pressure control who were on maximally tolerated medical therapy. We continued to administer maximum medical therapy for glaucoma. Study medications were either apraclonidine hydrochloride 0.5% or placebo (apraclonidine's vehicle). Patients were instructed to take the study medication every eight hours. We measured intraocular pressure, change in intraocular pressure from baseline, and the number of eyes requiring surgery after the addition of study medication.


RESULTS
Fifty-two (60%) of 86 patients treated with apraclonidine maintained adequate intraocular pressure control throughout the study and avoided surgery, compared with 28 (32%) of 88 patients treated with placebo (P < .001). Apraclonidine treatment resulted in significantly more patients attaining an additional 20% reduction or more in intraocular pressure from baseline and an intraocular pressure less than or equal to 20 mm Hg (P < .05). The most common ocular complication was conjunctival hyperemia (11 of 86 patients, 12.8%). The most frequent nonocular problem was dry mouth (four patients, 4.7%).


CONCLUSIONS
Apraclonidine appeared to be safe in all eyes and efficacious in some eyes. It significantly lowered intraocular pressure when used in combination with maximally tolerated medical therapy, which delayed or prevented further glaucoma surgery for at least 90 days in 52 (60%) of 86 treated patients.
Robin
A L
AL
Department of Ophthalmology, Johns Hopkins University, Baltimore, Maryland, USA.
Ritch
R
R
Shin
D H
DH
Smythe
B
B
Mundorf
T
T
Lehmann
R P
RP
D000316:Adrenergic alpha-Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D000319:Adrenergic beta-Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002257:Carbonic Anhydrase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D003000:Clonidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D008916:Miotics / Q000009:adverse effects / Q000627:therapeutic use; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D013566:Sympathomimetics / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D000319:Adrenergic beta-Antagonists; D002257:Carbonic Anhydrase Inhibitors; D008916:Miotics; D009883:Ophthalmic Solutions; D013566:Sympathomimetics; C016986:apraclonidine; D003000:Clonidine