PURPOSE. To assess the safety and IOP-lowering efficacy of travoprost 0.004% (Travatan) compared to latanoprost 0.005% and timolol 0.5% in patients with OAG or OH.
METHOD. Three prospective randomized double-masked trials (12, 9 and 6 month treatment periods) compared Travatan QD (N=591) to timolol 0.5% BID (N=579). The 1 year trial compared Travatan QD (N= 197) to latanoprost 0.005% QD (N= 193) and timolol BID (N=195). Efficacy evaluations included mean IOP and IOP change from baseline at 8 or 9 AM, 10 or 11 AM, and 4 PM.
RESULTS. Maximum IOP change from baseline was observed in the 9-month trial for Travatan (-8.0 to -8.9 mm Hg; 30-33%). Timolol reduced IOP from 6.4 to 7.9 mm Hg; 25-29%). In that trial, 98% of patients were non-black. For the 1-year study, mean IOP reductions (mm Hg) ranged from 6.6-8.1 (Travatan), 6.2-8.1 (latanoprost) and 5.1 to 6.7 (timolol) (78% non-black, 22% blacks). Results in the 6-month study were similar. Travatan was better than latanoprost at 4 PM (17.7 vs 18.5 mm Hg; p=0.019) in all patients. Data pooled over the 3 studies showed that Travatan was significantly more effective than timolol in reducing IOP in black patients by up to 3.9 mm Hg (p=0.0001; up to 4.6 mm Hg in the 1 year study, p=0.0001). In the 1 year trial in blacks, Travatan lowered IOP to 17.2 mm Hg versus 18.6 for latanoprost (p=0.0064). Iris pigmentation rates were 5% (latanoprost), 1-3.6% (Travatan) and 0% (timolol). Average hyperemia was trace to mild for all groups. No serious, unexpected treatment-related adverse events were reported for any group.
CONCLUSIONS. Travoprost is superior to timolol with better diurnal control than latanoprost in OAG or OH patients. Travoprost significantly lowers IOP in both black and non-black patients, with superior IOP control in blacks. Travoprost is safe and well tolerated.