The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension.
OBJECTIVE
This study compared the intraocular pressure (IOP)-lowering efficacy of 2 fixed combination products, brinzolamide 1%/timolol 0.5% suspension (Azarga, Brinz/Tim) and dorzolamide 2%/timolol 0.5% solution (Dorz/Tim), in patients with open-angle glaucoma or ocular hypertension who required a change in therapy due to elevated IOP while receiving IOP-lowering medication.


METHODS
This was a one-year, multicenter, randomized, double-masked, active-controlled, parallel-group trial of Brinz/Tim and Dorz/Tim. IOP assessments were taken at 8 and 10 AM at week 2 and months 3 and 9, and at 8 AM, 10 AM, and 4 PM at months 6 and 12. Primary efficacy was a noninferiority comparison of mean IOP at the three month 6 time points.


RESULTS
Of the 437 patients enrolled, 220 dosed Brinz/Tim whereas 217 dosed Dorz/Tim twice daily. Brinz/Tim produced IOP-lowering efficacy comparable to Dorz/Tim, with the upper 95% confidence limits for the differences between groups within +1.5 mm Hg at all assessment times, including the month 6 primary efficacy time points, establishing noninferiority. Differences in means numerically favored Brinz/Tim at 9 of 12 study visits and times. The IOP reductions ranged from 7.2 to 9.2 mm Hg for Brinz/Tim and from 7.4 to 8.9 mm Hg for Dorz/Tim. Although a similar overall safety profile was observed between the 2 treatment groups, Brinz/Tim showed significantly less ocular irritation (2.7% vs. 10.6%; P=0.0009) than Dorz/Tim.


CONCLUSIONS
Brinz/Tim suspension provides statistically significant and clinically relevant IOP-lowering efficacy that is noninferior to Dorz/Tim. Additionally, Brinz/Tim affords an ocular comfort advantage compared with Dorz/Tim.
Manni
Gianluca
G
University of Rome, Tor Vergata, Bietti Foundation IRCSS, Rome, Italy. glmanni@inwind.it
Denis
Phillipe
P
Chew
Paul
P
Sharpe
Elisabeth D
ED
Orengo-Nania
Silvia
S
Coote
Michael A
MA
Laganovska
Guna
G
Volksone
Lasma
L
Zeyen
Thierry
T
Filatori
Isabella
I
James
John
J
Aung
Tin
T
D000287:Administration, Topical; 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*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D011446:Prospective Studies; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013843:Thiazines / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D013999:Timolol / Q000009:adverse effects / Q000627:therapeutic use*; D014065:Tonometry, Ocular; D016896:Treatment Outcome; D055815:Young Adult
D000319:Adrenergic beta-Antagonists; D002257:Carbonic Anhydrase Inhibitors; D004338:Drug Combinations; D013449:Sulfonamides; D013843:Thiazines; D013876:Thiophenes; D013999:Timolol; C111827:brinzolamide; C062765:dorzolamide