Purpose. To establish the safety,
efficacy, and dosing regimen with travoprost (0.0001% to 0.006%), a new
prostaglandin analog, dosed QD in patients with ocular hypertension (OHT) and
open-angle glaucoma (OAG). Methods. Two 4-week randomized, double-masked,
parallel design, placebo-controlled studies were conducted in patients (OHT and
OAG). In Study 1, 138 patients
were randomized to vehicle and travoprost 0.0001%, 0.001%, 0.002% and dosed at
8AM. In Study 2, 227 patients were
randomized to vehicle and travoprost 0.001%, 0.002% 0.004% and 0.006% and dosed
at 8 PM. Safety assessments
included adverse events, visual acuity, ocular signs, pupil diameter, iris
color, ocular flare and hyperemia, pulse and blood pressure, and laboratory
analysis of blood and urine.
Baseline IOPs were from 24 to 36mmHg at 8am, 21 to 36mmHg at 10am, 4pm
and 8pm on two eligibility visits.
Results. All
concentrations of travoprost were shown to have no safety-related issues. Ocular hyperemia was minimal and
dose-dependant except with the 0.0001% concentration. The 0.004% dose is at the top of the dose-response curve
with IOP reductions ranging from 6.8 to 8.2mmHg (-28% to -31%). Dosing in the AM or PM provided similar
reductions in IOP. Conclusions. Travoprost, the active in TRAVATAN™, is
a safe and effective new prostaglandin analog that potently lowers and controls
IOP with QD dosing in the morning or evening. E1, C22.