A 3-month comparison of efficacy and safety of brimonidine-purite 0.15% and brimonidine 0.2% in patients with glaucoma or ocular hypertension.
OBJECTIVE
To compare the efficacy and safety of brimonidine Purite 0.15% (ALPHAGAN P) BID with brimonidine 0.2% (ALPHAGAN) BID in patients with glaucoma or ocular hypertension.


METHODS
3-month, multicenter, randomized, double-masked trial. Eligible patients were taking brimonidine 0.2% BID for at least 6 weeks prior to study entry and their intraocular pressure (IOP) was < or = 21 mm Hg. Patients were randomly assigned to receive either brimonidine Purite 0.15% BID (n = 203) or brimonidine 0.2% BID (n = 204). Scheduled visits were prestudy, baseline, and weeks 2, 6 and 12. IOP was measured at hour 0 and hour 2 to evaluate efficacy. Safety was measured by monitoring adverse events. Patient satisfaction and comfort were also evaluated at all visits.


RESULTS
There was no statistically significant difference between the brimonidine 0.2% and brimonidine Purite 0.15% groups with respect to mean IOP at baseline. The IOP-lowering efficacy of brimonidine Purite 0.15% was equivalent to that of brimonidine 0.2% and both study treatments maintained IOP-lowering effects of brimonidine 0.2%. There were no significant between-group differences in mean IOP. The differences in the mean IOPs were < or = 0.26 mm Hg and the mean change from baseline IOP was < or = 0.35 mm Hg at all follow-up time points. There were no statistically significant differences between the two groups in the overall incidence of adverse events. The most commonly reported treatment-related adverse events were conjunctival hyperemia and allergic conjunctivitis: both were mild in severity.


CONCLUSIONS
Brimonidine Purite 0.15% dosed BID provides equal IOP-lowering efficacy to brimonidine 0.2% BID. Patients previously controlled on brimonidine 0.2% can be successfully switched to brimonidine Purite 0.15%.
Mundorf
Tom
T
tommundorf@aol.com
Williams
Robert
R
Whitcup
Scott
S
Felix
Carlos
C
Batoosingh
Amy
A
D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000068438:Brimonidine Tartrate; D003228:Conjunctiva / Q000098:blood supply; D003233:Conjunctivitis, Allergic / Q000139:chemically induced / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005901:Glaucoma / Q000188:drug therapy*; D006801:Humans; D006940:Hyperemia / Q000139:chemically induced / Q000503:physiopathology; D007429:Intraocular Pressure / Q000187:drug effects; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D011810:Quinoxalines / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index
D000316:Adrenergic alpha-Agonists; D011810:Quinoxalines; D000068438:Brimonidine Tartrate