Safety and toleration
hyperaemia, infections, pyrexia, pruritus, ocular and extra-ocular adverse
EXCESSIVE LACRIMATION, HYPERAEMIA, ADVERSE EVENTS, INFECTIONS, EVENTS
A total of 39 instances of adverse events were reported in 24 patients during the course of the study. None of these met criteria for seriousness. Other than 2 events in 2 patients in the control group that were judged by the investigators to be of moderate severity, all events were mild. None of the events required interruption or discontinuation of study medication.Both events that were judged to be of moderate severity related to pyrexia presumed to be of infections origin not requiring hospitalization. Both events occurred in the control group several weeks after start of study medication, and resolved within 48 h with supportive therapy. Relationship to study drugs was judged by the investigators to be unlikely for both events and the study medication was not withdrawn in either case.Of the 39 events reported during the course of the study, 14 related to eye discomfort coded as irritation, discharge, pruritus, excessive lacrimation, or hyperaemia. As shown in Table 
Safety and Toleration: Number of adverse events and patients reporting eventsNone of the inter-group differences in the number of ocular and extra-ocular adverse events or the number of patients reporting such events was found to be statistically significant at an α value of 0.05 using a 2 × 2 chi-square test with Yates correction.