Abstract

In two phase 3, double-blind, vehicle-controlled trials, treatment-emergent adverse events (TEAEs) were collected weekly, and TEAEs of special interest, including mydriasis and blurred vision, were predefined. Ocular TEAEs were experienced by 11.1% (51/459) of GT-treated patients (6/51 were ≤16 years of age) and 1.3% (3/232) of vehicle-treated patients (0/3 were ≤16 years); nearly all of these patients had mild or moderate events (53/54, 98.2%). The most common ocular TEAE was mydriasis, which occurred in 6.8% (31/459) of GT-treated patients (4/31 were ≤16 years) and no vehicle-treated patients; most patients had mild events (21/31 patients, 67.8%).

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