The efficacy and safety of timolol maleate versus brinzolamide each given twice daily added to travoprost in patients with ocular hypertension or primary open-angle glaucoma.
OBJECTIVE
To compare the efficacy and safety of timolol maleate 0.5% versus brinzolamide 1% when added to travoprost 0.004% in patients with ocular hypertension or primary open-angle glaucoma.


METHODS
A prospective, double-masked, randomized, active-controlled, parallel comparison.


METHODS
Qualified patients at Visit 1 were placed on travoprost dosed every evening for 4 weeks and then were randomized at baseline (Visit 2) to the addition of timolol maleate or brinzolamide each given twice daily. Patients returned to clinic at Week 4 (Visit 3) for a safety visit and Week 12 (Visit 4) for an efficacy visit. At Visits 2 and 4 the intraocular pressure (IOP) was measured at 08:00, 12:00, and 16:00 hours.


RESULTS
Ninety-seven patients on brinzolamide had a baseline diurnal IOP of 21.5+/-2.2 mmHg and 95 on timolol maleate had 21.3+/-2.5 mmHg, each added to travoprost. The diurnal mean IOP at Week 12 was 18.1+/-2.7 mmHg for brinzolamide and 18.1+/-3.0 mmHg for timolol maleate (p=0.96). There was no statistical difference found between treatment groups in the absolute level of pressure, or in the reduction in IOP from baseline, at each time point or for the diurnal curve (p>0.05). There was no significant difference for any adverse event between groups (p>0.05), with the most common side effect being conjunctival hyperemia in 15/97 (16%) brinzolamide and 6/95 (6%) timolol treated patients (p=0.06).


CONCLUSIONS
This study showed that brinzolamide provides similar safety and efficacy compared to timolol maleate when added to travoprost.
Holló
G
G
Department of Ophthalmology, Semmelweis University, Budapest, Hungary.
Chiselita
D
D
Petkova
N
N
Cvenkel
B
B
Liehneova
I
I
Izgi
B
B
Berta
A
A
Szaflik
J
J
Turacli
E
E
Stewart
W C
WC
D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002257:Carbonic Anhydrase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D002940:Circadian Rhythm; D003008:Cloprostenol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy / Q000503:physiopathology; D011446:Prospective Studies; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D013843:Thiazines / Q000008:administration & dosage* / Q000009:adverse effects; D013999:Timolol / Q000008:administration & dosage* / Q000009:adverse effects; D014065:Tonometry, Ocular; D000069557:Travoprost; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D002257:Carbonic Anhydrase Inhibitors; D013449:Sulfonamides; D013843:Thiazines; D003008:Cloprostenol; D013999:Timolol; C111827:brinzolamide; D000069557:Travoprost