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William C. Stewart, MD; Robert Laibovitz, MD; Barry Horwitz, MD; Robert H. Stewart, MD; Robert Ritch, MD; Michael Kottler, MD; Apraclonidine Primary Therapy Study Group

Arch Ophthalmol. 1996;114(8):938-942.

Abstract
Objective
To compare long-term intraocular pressure (IOP)-lowering efficacy of 0.25% and 0.5% apraclonidine hydrochloride with 0.5% timolol maleate.

Design
Multicenter, randomized, double-masked trial. Adult patients of either sex diagnosed as having open-angle glaucoma or ocular hypertension were enrolled following appropriate washout from all ocular hypotensive medications. Morning IOPs of 22 to 35 mm Hg were required for entry. Patients received 0.25% or 0.5% apraclonidine 3 times a day or 0.5% timolol twice a day for 90 days. Intraocular pressure was measured at 8 AM (before morning dosing) and at 4 PM (8 hours after dosing) on days 1, 30, and 90, and only at 8 AM on day 14.

Results
All 3 medications significantly reduced IOP from baseline at all observation times (P<.001): 0.5% apraclonidine reduced IOP more than 0.25% apraclonidine; no significant difference was observed between 0.5% apraclonidine and 0.5% timolol 8 hours after dosing on days 1, 30, and 90; and a significant difference (P<.05) in favor of 0.5% timolol over 0.25% apraclonidine was observed 8 hours after dosing on day 30. At all morning visits following evening dosing, 0.5% timolol significantly reduced IOP more than both concentrations of apraclonidine.

Conclusions
Both 0.25% and 0.5% apraclonidine significantly reduce IOP when used as primary ocular hypotensive medication. Although 0.25% and 0.5% apraclonidine reduce IOP to a similar degree as 0.5% timolol 8 hours after morning dosing, neither concentration is as effective for reducing morning IOP after evening dosing.

Author Affiliations
From Pharmaceutical Research Corporation, Charleston, SC (Dr W. C. Stewart); Eye Research Associates, Austin, Tex (Dr Laibovitz) and Houston, Tex (Dr Horwitz); Houston Eye Associates (Dr R. H. Stewart); New York (NY) Eye and Ear Infirmary (Dr Ritch); and Rocky Mountain Eye Center, Salt Lake City, Utah (Dr Kottler). Participants of the Apraclonidine Primary Therapy Study Group are listed on page 940. The authors have no proprietary interest in apraclonidine or timolol.

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