Conjunctival hyperaemia and other ocular adverse effects on healthy African subjects after single dosing with 0.004%...

Conjunctival hyperaemia and ocular adverse effects induced by a single dose of 0.004% travoprost in healthy subjects were evaluated. A randomized, double-blind cross-over placebo controlled study was done. Conjunctival hyperaemia was evaluated clinically at 12, 24, 36 and 72 hours after dosing and volunteers reported all ocular adverse effects. 15 out of 20 subjects (70%) dosed with travoprost compared with 2 out of 20 (10%) dosed with placebo developed clinically moderate hyperaemia. However, significant difference in hyperaemia in the two groups occurred only at 24 hours (P < 0.048). The hyperaemia cleared by 72 hours. Travoprost may cause significantly short-term conjunctival hyperaemia even after a single dose in the eyes of healthy African subjects.