Brimonidine and timolol fixed-combination therapy versus monotherapy: a 3-month randomized trial in patients with glaucoma or ocular hypertension.
OBJECTIVE
The aim of this study was to compare the safety and intraocular pressure (IOP)- lowering efficacy of a fixed combination of brimonidine 0.2% and timolol 0.5% (fixed brimonidine/ timolol) versus each drug used as monotherapy.


METHODS
Patients with glaucoma or ocular hypertension were randomized to receive fixed brimonidine/timolol BID (n = 385), brimonidine 0.2% TID (n = 382), or timolol 0.5% BID (n = 392) in a multicenter, double-masked study. The primary outcome measure was decrease from baseline IOP.


RESULTS
Over all follow-up measurements, the mean decrease from baseline IOP ranged from 4.9 to 7.6 mmHg with brimonidine/timolol, from 3.1 to 5.5 mmHg with brimonidine, and from 4.3 to 6.2 mmHg with timolol. Mean IOP reductions from baseline were significantly larger with fixed brimonidine/timolol than with timolol at all follow-up measurements (P < or = 0.026); the difference was greater than 1.5 mmHg at 10 AM (peak effect for each treatment). Mean IOP reductions from baseline were significantly larger with fixed brimonidine/ timolol than with brimonidine at 8 AM, 10 AM, and 3 PM (P < 0.001); the difference was greater than 1.5 mmHg. The rate of discontinuations owing to adverse events was 3.6% in the fixed timolol/brimonidine group.


CONCLUSIONS
The fixed combination of brimonidine and timolol was well-tolerated and provided significantly better IOP control compared with either brimonidine or timolol used alone.
Craven
E Randy
ER
Glaucoma Consultants of Colorado, Littleton, CO, USA. ercraven@yahoo.com
Walters
Thomas R
TR
Williams
Robert
R
Chou
Connie
C
Cheetham
Janet K
JK
Schiffman
Rhett
R
D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068438:Brimonidine Tartrate; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005901:Glaucoma / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy / Q000503:physiopathology; D011810:Quinoxalines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013999:Timolol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D000319:Adrenergic beta-Antagonists; D004338:Drug Combinations; D011810:Quinoxalines; D000068438:Brimonidine Tartrate; D013999:Timolol