3 %) 1 (0 3 %) 6 (3 5 %) 0 Ear pain 1 (0 3 %) 0 0 0 Dysgeusia 0 1

3 %) 1 (0.3 %) 6 (3.5 %) 0 Ear pain 1 (0.3 %) 0 0 0 Dysgeusia 0 1 (0.3 %) 0 0 Pyrexia 1 (0.3 %) 0 0 0 Nasopharyngitis 2 (0.6 %) 0 1 (0.6 %) 0 Otitis media 1 (0.3 %) 0 0 0 Upper respiratory tract infection 1 (0.3 %) 0 0 0 Bronchitis 0 0 1 (0.6 %) 0 Gastroenteritis, viral 0 0 1 (0.6 %) 0 Intervertebral disc protrusion 1 (0.3 %) 0 0 0 Cyst 0 0 1 (0.6 %) 0 Headache 1 (0.3 %) 0 1 (0.6 %) 0 Nasal congestion 1 (0.3 %) 0 0 0 Rhinitis, allergic #ARRY-162 in vivo randurls[1|1|,|CHEM1|]# 0 0 1 (0.6 %) 0 aIncludes events considered by investigator as “possibly”, “probably”, or “definitely” related; events with unknown relationship were counted as “probably related” 3.6 Visual Acuity (VA) No subject in either treatment group had a reduction in VA

by more than two lines at any visit. Most subjects showed either an improvement or no change from baseline at Visit 2 (92.1 %, besifloxacin; 96.6 % vehicle) and Visit 3 (93.7 %, besifloxacin; 95.2 %, vehicle). VA findings were similar for

treated fellow eyes. 3.7 Biomicroscopy Overall, very few subjects (<2 % in either treatment group) presented treatment emergent biomicroscopy findings in the study eye at any visit. There were no significant differences noted between treatment groups selleck products for the frequency of any biomicroscopy findings at Day 8 [6 (1.8 %) besifloxacin subjects vs. 3 (1.8 %) vehicle subjects] or Day 11 [3 (0.9 %) besifloxacin subjects vs. 0 vehicle subjects]. Findings were similar for treated fellow eyes. Likewise, there were no significant differences

between treatment groups for the specific slit lamp evaluations of the eyelid, conjunctiva, cornea, anterior chamber, lens, or vitreous. 3.8 Ophthalmoscopy There were no treatment emergent ophthalmoscopy findings on Day 11 in either the study eyes or treated fellow eyes for either treatment group. 3.9 Bacterial Eradication (Efficacy) 3.9.1 Overall As expected, at Visit 2 (Day 8), besifloxacin-treated study eyes had a higher rate of bacterial eradication than vehicle-treated study eyes [83.5 % Methocarbamol (172/206) vs. 45.0 % (36/80), respectively; Fig. 1a]. A similar pattern was observed at Day 11, although the difference between the groups was smaller [84.5 % (169/200) vs. 57.8 % (48/83)]. Fig. 1 Bacterial eradication rates in besifloxacin- and vehicle-treated baseline-designated study eyes following TID treatment for 7 days (modified ITT population). Data shown for a overall bacterial species, b Gram-positive species, and c Gram-negative species 3.9.2 Eradication of Bacterial Species According to Gram Stain Bacterial eradication by baseline infection with either Gram-positive or Gram-negative species did not differ significantly from overall species. For infections caused by Gram-positive bacterial species (Fig. 1b), besifloxacin-treated eyes had a higher rate of bacterial eradication in the study eye at both Visit 2 and Visit 3 compared to vehicle-treated eyes.

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