title: Effects of SofZia-preserved travoprost and benzalkonium chloride-preserved latanoprost on the ocular surface -- a multicentre randomized single-masked study.
abstract: OBJECTIVE
  To assess the effect of SofZia-preserved travoprost on ocular surface conditions in comparison with benzalkonium chloride (BAK)-preserved latanoprost.
  
  
  METHODS
  A prospective randomized multicentre single-masked comparative study. Patients with open-angle glaucoma or ocular hypertension who had been treated with BAK-preserved latanoprost 0.005% (Xalatan(®) ) monotherapy for at least 3 months. Patients were enrolled at 23 facilities. Patients were randomly divided into the X-X group, continuous use of Xalatan(®) , or the X-T group, switching from Xalatan(®) to SofZia-preserved travoprost 0.004% (TravatanZ(®) ), and followed for 3 months. The superficial punctate keratopathy (SPK), conjunctival epitheliopathy, hyperaemia, tear break-up time (TBUT) and intraocular pressure (IOP) were examined for each patient in a masked manner. Changes in the frequency of keratoconjunctival epitheliopathy were evaluated 3 months after study initiation. Intra- and intergroup comparisons of changes in SPK, conjunctival epitheliopathy, hyperaemia, TBUT and IOP were also carried out.
  
  
  RESULTS
  Two hundred twenty patients participated and 215 completed the 3-month study. The frequency of keratoconjunctival epitheliopathy significantly decreased in the X-T group (p = 0.036) and the intergroup difference was also significant (p = 0.001). SPK scores and TBUT were significantly improved in the X-T group (p = 0.034, 0.049), also with significant intergroup differences in the cornea excluding the inferior area and TBUT. There were no significant intergroup differences in changes of the hyperaemia scores and the IOP reduction.
  
  
  CONCLUSIONS
  Switching to SofZia-preserved travoprost after BAK-preserved latanoprost resulted in a lower incidence of keratoconjunctival epitheliopathy, especially in the cornea, with no clinically relevant changes in hyperaemia and IOP.
authors.affiliation: Department of Ophthalmology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Aihara
authors.forename: Hiromi
authors.initials: H
authors.lastname: Oshima
authors.forename: Makoto
authors.initials: M
authors.lastname: Araie
mesh_terms: D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001548:Benzalkonium Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D003008:Cloprostenol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003228:Conjunctiva / Q000187:drug effects; D003229:Conjunctival Diseases / Q000139:chemically induced; D003315:Cornea / Q000187:drug effects; D003316:Corneal Diseases / Q000139:chemically induced; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000009:adverse effects / Q000627:therapeutic use*; D016037:Single-Blind Method; D014065:Tonometry, Ocular; D000069557:Travoprost; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001548:Benzalkonium Compounds; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D011461:Prostaglandins F, Synthetic; D003008:Cloprostenol; D000077338:Latanoprost; D000069557:Travoprost