All four TEAEs were

considered unrelated/unlikely related to study treatment. In the vehicle group, four subjects discontinued treatment or study due to different reasons, including TEAEs: lack of efficacy and worsening of conjunctivitis, randomization error and post-traumatic pain, investigator decision and worsening of conjunctivitis, consent withdrawal and conjunctivitis. Three of these TEAEs were considered unrelated to study treatment and one was considered possibly related to study drug (lack of efficacy). Other primary reasons for discontinuation included withdrawal of consent Barasertib cost (n = 1 vehicle group), lost to follow-up (n = 1 besifloxacin group), investigator decision (n = 1 besifloxacin; n = 3 vehicle), and other reasons (n = 3 besifloxacin; n = 1 vehicle). 3.2 Compliance In both the mITT and safety population, the percentage of patients considered compliant (80–120 % of doses selleck chemical administered) was ≥98 % in both treatment groups. 3.3 Exposure to Study SNX-5422 supplier Treatment A total of 344 subjects were exposed to besifloxacin, while 170 subjects were exposed to vehicle (safety population). Among study eyes, mean ± SD exposure times to study treatment were similar in the besifloxacin (6.97 ± 0.39 days) and vehicle (6.92 ± 0.52 days) treatment groups

(Table 2). When considering all treated eyes (study eyes plus any treated fellow eyes), mean ± SD exposure times were 11.42 ± 3.43 eye-days in the besifloxacin treatment group and 11.56 ± 3.38 eye-days in the vehicle treatment group. Table 2 Exposure to study treatment (safety population—study eyes) Number of eye days Besifloxacin, n (%) (N = 344) Vehicle, n (%) (N = 170) ≤6 8 (2.3 %) 5 (2.9 %) 7 332 (96.5 %) 164 (96.5 %) 8–11 4 (1.2 %) 1 (0.6 %) ≥12 0 0 Mean ± SD eye days 6.97 ± 0.39 6.92 ± 0.52 3.4 Ocular Treatment-Emergent Adverse Events (TEAEs) selleck Overall, 31 ocular TEAEs were reported by 28 subjects in the study eye (Table 3), with no significant difference noted

between treatment groups. In the besifloxacin group, 19 events were reported in 17/344 (4.9 %) patients; 12 events were reported in 11/170 (6.5 %) vehicle patients (p = 0.5362). Only two ocular events (one case of instillation site reaction in each of the besifloxacin and vehicle groups) were considered “definitely related” to study treatment by the investigator; these events were both considered mild and resolved without treatment. No subjects were removed from the study due to these events. One event of conjunctivitis in the vehicle group was considered “probably related” to treatment. Four TEAEs (punctate keratitis, instillation site erythema, instillation site pain, and instillation site reaction) in the besifloxacin group were considered “possibly related” to treatment, while four TEAEs (conjunctivitis, conjunctival edema, punctate keratitis, and instillation site irritation) were considered “possibly related” to treatment in the vehicle group.