|a. Summary of the safety profileThe most frequently occurring adverse reaction during clinical trials was vision blurred.b. Tabulated list of adverse reactionsThe following adverse reactions are classified according to the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post marketing spontaneous reports.|
|System Organ Classification||MedDRA Preferred Term (v.12.0)|
|Immune system disorders
|Nervous system disorders
dry eye (residual), eyelid disorder, abnormal sensation in eye, foreign body sensation in eyes, ocular discomfort.
photophobia, hypoaesthesia eye, eye pruritus, eye irritation, ocular hyperaemia.
erythema of eyelid, eye swelling, eye pain, eye discharge, eyelid margin crusting, lacrimation increased.
|General disorders and administration site conditions