Safety assessment
ICH
ADVERSE EVENTS, ADVERSE EVENT, DISEASE
Safety was assessed on the basis of incidence and severity of adverse events noted by investigators or reported by study participants at any time during the course of the study. Adverse events, whether local to the eye or systemic, were defined as any unfavourable or untoward sign, symptom or disease that occurred during the course of the trial irrespective of a causal relationship to study drugs. Adverse events would be classified as “serious” if they met criteria for seriousness defined in the International Conference on Harmonization (ICH) E2A guideline. Investigators were required to state their opinion on causal relationship of adverse events to the investigational products based on the WHO-UMC system for standardised case causality assessment.