This study evaluated the safety and intraocular pressure-lowering efficacy of two
concentrations of travoprost (0.0015% and 0.004%) compared with latanoprost 0.005%
and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension.
Eight hundred one patients with open-angle glaucoma or ocular hypertension were randomly
assigned to travoprost 0.0015%, travoprost 0.004%, latanoprost 0.005%, or timolol
0.5%. The efficacy and safety of travoprost (0.0015% and 0.004%) daily was compared
with latanoprost daily and timolol twice daily for a period of 12 months.
Travoprost was equal or superior to latanoprost and superior to timolol with mean
intraocular pressure over visits and time of day ranging from 17.9 to 19.1 mm Hg (travoprost
0.0015%), 17.7 to 19.1 mm Hg (travoprost 0.004%), 18.5 to 19.2 mm Hg (latanoprost),
and 19.4 to 20.3 mm Hg (timolol). For all visits pooled, the mean intraocular pressure
at 4 PM for travoprost was 0.7 mm Hg (0.0015%, P =.0502) and 0.8 mm Hg (0.004%, P
=.0191) lower than for latanoprost. Travoprost 0.004% was more effective than latanoprost
and timolol in reducing intraocular pressure in black patients by up to 2.4 mm Hg
(versus latanoprost) and 4.6 mm Hg (versus timolol). Based on a criterion of 30% or
greater intraocular pressure reduction from diurnal baseline or intraocular pressure
17 mm Hg or less, travoprost 0.0015% and 0.004% had an overall response to treatment
of 49.3% and 54.7%, respectively, compared with 49.6% for latanoprost and 39.0% for
timolol. Iris pigmentation change was observed in 10 of 201 of patients (5.0%) receiving
travoprost 0.0015%, six of 196 of patients (3.1%) receiving travoprost 0.004%, 10
of 194 of patients (5.2%) receiving latanoprost, and none of the patients receiving
timolol (0 of 196). The average ocular hyperemia score was less than 1 on a scale
of 0 to 3, indicating that on average patients experienced between none/trace and
mild for all treatment groups. There were no serious, unexpected, related adverse
events reported for any therapy.
Travoprost (0.0015% and 0.004%), a highly selective, potent prostaglandin F (FP) receptor
agonist, is equal or superior to latanoprost and superior to timolol in lowering intraocular
pressure in patients with open-angle glaucoma or ocular hypertension. In addition,
travoprost 0.004% is significantly better than either latanoprost or timolol in lowering
intraocular pressure in black patients. Travoprost is safe and generally well tolerated
in the studied patient population.