Comparison of travoprost 0.0015% and 0.004% with timolol 0.5% in patients with elevated intraocular pressure: a 6-month, masked, multicenter trial.
OBJECTIVE
To compare the safety and intraocular pressure (IOP)-lowering efficacy of once-daily travoprost (0.0015% and 0.004%) to twice-daily timolol 0.5%.


METHODS
Prospective, 6-month, randomized, controlled, multicenter, double-masked, phase III study.


METHODS
Six hundred five patients with open-angle glaucoma or ocular hypertension.


METHODS
Patients with an 8 AM IOP between 24 to 36 mmHg in at least one eye (the same eye) at two eligibility visits received either travoprost 0.0015%, travoprost 0.004% (dosed every day), or timolol 0.5% (dosed twice daily).


METHODS
Mean IOP at 8 AM, 10 AM, and 4 PM in the patient's eye with the higher baseline IOP.


RESULTS
The mean IOP was significantly lower for both concentrations of travoprost compared with timolol. Travoprost was statistically superior to timolol at 9 of 13 visits, with differences in IOP reductions ranging from 0.9 to 1.8 mmHg (0.0015%) and 10 of 13 visits with differences in IOP reductions from 0.9 to 2.4 mmHg (0.004%). Mean IOP changes from baseline ranged from -6.0 to -7.5 mmHg (0.0015%), -6.5 to -8.0 mmHg (0.004%), and -5.2 to -7.0 mmHg for timolol. Hyperemia was experienced at rates of 29.2% (59 of 202) for travoprost 0.0015%, 42.8% (86 of 201) for travoprost 0.004%, and 8.9% (18 of 202) for timolol. Iris pigmentation changes were observed in 1.0% (2 of 200) of patients receiving travoprost 0.004% with no changes noted in the travoprost 0.0015% group or the timolol group. A decrease in pulse and systolic blood pressure was observed in the timolol group. There were no other clinically relevant or statistically significant changes from baseline in ocular signs or laboratory values, and no serious, related, unexpected adverse events were reported for any group.


CONCLUSIONS
Travoprost (0.0015% and 0.004%), dosed once daily in the evening, is statistically superior or equal to timolol 0.5% dosed twice daily at all treatment visits during this 6-month study. IOP reductions of up to 2.0 mmHg greater than timolol were found in the travoprost 0.004% pooled data group. Travoprost is safe and well tolerated in patients with open-angle glaucoma or ocular hypertension.
Fellman
Ronald L
RL
Glaucoma Associates of Texas, Dallas, Texas, USA.
Sullivan
E Kenneth
EK
Ratliff
Marla
M
Silver
Lewis H
LH
Whitson
Jess T
JT
Turner
F Darell
FD
Weiner
Alan L
AL
Davis
Alberta A
AA
D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D003008:Cloprostenol / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D012449:Safety; D013999:Timolol / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000069557:Travoprost; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D003008:Cloprostenol; D013999:Timolol; D000069557:Travoprost