Efficacy and safety of a fixed combination of travoprost 0.004%/timolol 0.5% ophthalmic solution once daily for open-angle glaucoma or ocular hypertension.
OBJECTIVE
To compare the efficacy of a fixed combination of travoprost 0.004%/timolol 0.5% every day in the morning with a concomitant regimen of timolol 0.5% every day in the morning, plus travoprost 0.004% every day in the evening; and timolol 0.5% twice daily on the intraocular pressure (IOP) of subjects with open-angle glaucoma or ocular hypertension over 3 months.


METHODS
Prospective, randomized, double-masked, parallel-group, active-controlled, multicenter trial.


METHODS
Patients comprised adult subjects (n = 403) of either gender with open-angle glaucoma or ocular hypertension in at least one eye. To qualify, the IOP had to be between 22 to 36 mm Hg in the same eye at two consecutive eligibility visits. The primary outcome variable was IOP measured with a Goldmann applanation tonometer.


RESULTS
Mean IOP ranged from 16.2 to 17.4 mm Hg with the combination travoprost/timolol compared with 15.4 to 16.8 mm Hg in the concomitant travoprost + timolol group, from baselines of 23.1 to 25.6 mm Hg and 22.9 to 25.0 mm Hg, respectively. The fixed combination of travoprost/timolol significantly lowered IOP by 7 to 9 mm, similar to the IOP reductions observed with concomitant therapy. The most frequent ocular adverse event was hyperemia that occurred in 14.3% and 23.4% of subjects treated with travoprost/timolol combination and concomitant travoprost + timolol, respectively.


CONCLUSIONS
Travoprost/timolol combination produces greater IOP reductions than the positive control, timolol 0.5%, and reductions that were similar to concomitant travoprost + timolol. This study demonstrates that the fixed combination of travoprost/timolol produces significant and clinically relevant reductions of IOP in a once-daily dosing regimen.
Schuman
Joel S
JS
UPMC Eye Center, Eye and Ear Institute, Pittsburgh, Pennsylvania 15213, USA. schumanjs@upmc.edu
Katz
Gregory J
GJ
Lewis
Richard A
RA
Henry
J Charles
JC
Mallick
Sushanta
S
Wells
David T
DT
Sullivan
E Kenneth
EK
Landry
Theresa A
TA
Bergamini
Michael V W
MV
Robertson
Stella M
SM
D000959:Antihypertensive Agents / Q000008:administration & dosage*; D003008:Cloprostenol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; 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; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D011446:Prospective Studies; D012449:Safety; D013999:Timolol / Q000008:administration & dosage*; D000069557:Travoprost; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D004338:Drug Combinations; D009883:Ophthalmic Solutions; D003008:Cloprostenol; D013999:Timolol; D000069557:Travoprost