The safety and intraocular pressure-lowering efficacy of brimonidine tartrate 0.15% preserved with polyquaternium-1.
OBJECTIVE
The safety and intraocular pressure (IOP)-lowering efficacy of brimonidine tartrate 0.15% preserved with polyquaternium-1 were evaluated and compared with brimonidine tartrate 0.15% preserved with chlorine dioxide in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).


METHODS
Randomized, double-masked, parallel group, multicenter equivalence study.


METHODS
Eight hundred forty-two patients randomized to the study treatments.


METHODS
Patients with OAG or OHT and with qualifying IOP (22-36 mmHg at 8 am on 2 eligibility visits after an appropriate washout period from previous treatment) were assigned randomly to either brimonidine tartrate 0.15% preserved with polyquaternium-1 (brimonidine PQ) or brimonidine tartrate 0.15% preserved with chlorine dioxide (brimonidine P) dosed 3 times daily and were followed up for 6 months. Approximately one half of the study sites continued to follow up their patients for an additional 6 months to obtain longer-term safety data.


RESULTS
Brimonidine PQ produced statistically significant and clinically relevant reductions from baseline ranging from 4.3 to 6.5 mmHg, which were statistically and clinically equivalent to brimonidine P at all 18 visit days and times. No safety concerns were identified based on an assessment of ocular and cardiovascular parameters. Patient discontinuations resulting from adverse events were similar for both groups and most of these were a result of signs or symptoms of ocular allergic reaction.


CONCLUSIONS
Brimonidine PQ is equivalent in IOP-lowering efficacy and safety to brimonidine P.
Whitson
Jess T
JT
Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas 75390-9057, USA. Jess.Whitson@UTSouthwestern.edu
Ochsner
Katherine I
KI
Moster
Marlene R
MR
Sullivan
E Kenneth
EK
Andrew
Russell M
RM
Silver
Lewis H
LH
Wells
David T
DT
James
John E
JE
Bosworth
Charles F
CF
Dickerson
Jaime E
JE
Landry
Theresa A
TA
Bergamini
Michael V W
MV
D000316:Adrenergic alpha-Agonists / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000368:Aged; D000068438:Brimonidine Tartrate; D017606:Chlorine Compounds / Q000009:adverse effects / Q000493:pharmacokinetics; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005902:Glaucoma, Open-Angle / 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; D010087:Oxides / Q000009:adverse effects / Q000493:pharmacokinetics; D011108:Polymers / Q000009:adverse effects / Q000493:pharmacokinetics; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000493:pharmacokinetics; D011810:Quinoxalines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013810:Therapeutic Equivalency
D000316:Adrenergic alpha-Agonists; D017606:Chlorine Compounds; D004338:Drug Combinations; D010087:Oxides; D011108:Polymers; D011310:Preservatives, Pharmaceutical; D011810:Quinoxalines; D000068438:Brimonidine Tartrate; C058655:polyquaternium 1; C025109:chlorine dioxide