title: Comparison of the toxicity profile of benzalkonium chloride-preserved tafluprost and SofZia-preserved travoprost applied to the ocular surface.
abstract: OBJECTIVE
  To evaluate some clinically important features of benzalkonium chloride (BAK) toxicity by comparing tafluprost with 0.001% BAK and travoprost preserved with SofZia applied to the ocular surface of the eyes with glaucoma.
  
  
  METHODS
  This was a prospective, randomized, observer unmasked, multicenter crossover trial. A total of 195 patients were randomized and 174 patients completed the study at 19 clinics between November 2011 and August 2012. Topical BAK-preserved tafluprost or SofZia-preserved travoprost was newly administered or continued. Superficial punctate keratopathy (SPK), tear break-up time (BUT), the conjunctival hyperemia score, and intraocular pressure (IOP) were compared at the baseline visit, 4, and 12 weeks after the start of therapy. The eye drops were switched to another eye drop after 12 weeks of observation.
  
  
  RESULTS
  The total SPK and conjunctival hyperemia scores were significantly lower in the tafluprost compared with those in the travoprost phase (both P=0.038). There were no significant differences in the SPK scores of the superior area (P=0.679), central area (P=0.089), inferior area (P=0.090), and tear BUT (P=0.271). The IOP-lowering effects were similar (P=0.155).
  
  
  CONCLUSIONS
  SPK, hyperemia score, and tear BUT while using tafluprost with 0.001% BAK were not inferior compared with those caused by travoprost with SofZia.
authors.affiliation: 1 Department of Ophthalmology and Visual Science, Graduate School of Biomedical Sciences, Hiroshima University , Hiroshima, Japan .
authors.forename: Takashi
authors.initials: T
authors.lastname: Kanamoto
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Kiuchi
authors.forename: Masaki
authors.initials: M
authors.lastname: Tanito
authors.forename: Shiro
authors.initials: S
authors.lastname: Mizoue
authors.forename: Tomoko
authors.initials: T
authors.lastname: Naito
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Teranishi
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Hirooka
authors.forename: Ulfah
authors.initials: U
authors.lastname: Rimayanti
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D001548:Benzalkonium Compounds / Q000009:adverse effects* / Q000737:chemistry; D018592:Cross-Over Studies; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy / Q000473:pathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D009798:Ocular Hypertension / Q000188:drug therapy / Q000473:pathology; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects* / Q000737:chemistry; D011446:Prospective Studies; D011460:Prostaglandins F / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D000069557:Travoprost / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry
chemical_list: D000959:Antihypertensive Agents; D001548:Benzalkonium Compounds; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D011460:Prostaglandins F; C485333:tafluprost; D000069557:Travoprost