title: An anterior chamber toxicity study evaluating Besivance, AzaSite, and Ciprofloxacin.
abstract: OBJECTIVE
  We determined whether Besivance (Bausch & Lomb), AzaSite (Inspire Pharmaceuticals, Inc; both with DuraSite bioadhesive [InSite Vision, Inc]) and ciprofloxacin are toxic inside the anterior chamber.
  
  
  METHODS
  Randomized, masked, placebo-controlled animal study.
  
  
  METHODS
  Twenty New Zealand white rabbits (40 eyes) were randomized to 1 of 4 study groups: Besivance, AzaSite, ciprofloxacin, and balanced salt solution. Each eye was injected with 0.1 mL of the study medication. Clinical slit-lamp examinations were conducted at 24 and 48 hours after injection. All rabbits then were killed and all eyes were enucleated. We randomized eyes to either corneal vital staining or histopathologic examination. The main outcome measures were clinical and pathologic signs of toxicity.
  
  
  RESULTS
  The 2 DuraSite-based study groups (Besivance and AzaSite) showed clinically and pathologically significant differences when compared with the ciprofloxacin and balanced salt solution groups. Besivance and AzaSite eyes exhibited significantly similar and severe clinical damage, including severe corneal edema. Ciprofloxacin and balanced salt solution eyes appeared very similar and had only mild conjunctival injection and limbal vascularity. Vital staining and histopathologic evaluation revealed glaucomatous and toxic damage in eyes given DuraSite-based medications, whereas non-DuraSite groups showed minimal changes.
  
  
  CONCLUSIONS
  DuraSite blocks the trabecular meshwork and may be additionally toxic when introduced as a large bolus. Until the safety of these medications is established with further studies using smaller injected volumes, we recommend placement of a suture over a clear corneal wound if DuraSite-based medications are used.
authors.affiliation: Department of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah, Salt Lake City, UT 84132, USA. randallj.olson@hsc.utah.edu
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Ness
authors.forename: Nick
authors.initials: N
authors.lastname: Mamalis
authors.forename: Liliana
authors.initials: L
authors.lastname: Werner
authors.forename: Surekha
authors.initials: S
authors.lastname: Maddula
authors.forename: Don K
authors.initials: DK
authors.lastname: Davis
authors.forename: Eric D
authors.initials: ED
authors.lastname: Donnenfeld
authors.forename: Randall J
authors.initials: RJ
authors.lastname: Olson
mesh_terms: D000085:Acetates / Q000008:administration & dosage; D000818:Animals; D000867:Anterior Chamber / Q000187:drug effects*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000633:toxicity*; D001381:Azepines / Q000008:administration & dosage / Q000633:toxicity*; D017963:Azithromycin / Q000008:administration & dosage / Q000633:toxicity*; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000633:toxicity*; D003318:Corneal Opacity / Q000139:chemically induced; D004338:Drug Combinations; D016503:Drug Delivery Systems; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000633:toxicity*; D005901:Glaucoma / Q000139:chemically induced; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008903:Minerals / Q000008:administration & dosage; D011817:Rabbits; D011897:Random Allocation; D012965:Sodium Chloride / Q000008:administration & dosage; D014129:Trabecular Meshwork / Q000187:drug effects
chemical_list: D000085:Acetates; D000900:Anti-Bacterial Agents; D001381:Azepines; C030660:BSS solution; D004338:Drug Combinations; D024841:Fluoroquinolones; D008903:Minerals; D012965:Sodium Chloride; D002939:Ciprofloxacin; D017963:Azithromycin; C522124:besifloxacin