title: Ocular surface tolerability of prostaglandin analogs and prostamides in patients with glaucoma or ocular hypertension.
abstract: BACKGROUND
  There has been increased attention on the potential impact of the preservative benzalkonium chloride (BAK) on the ocular surface. This study compared the ocular surface tolerability of once-daily bimatoprost 0.01% and latanoprost 0.005% (both preserved with 0.02% BAK), and travoprost 0.004% preserved with sofZia™.
  
  
  METHODS
  A randomized, multicenter (15 sites), investigator-masked study enrolled patients with open-angle glaucoma or ocular hypertension who had received latanoprost monotherapy for at least 1 month. Patients were randomized to oncedaily bimatoprost (n = 56), travoprost (n = 53), or latanoprost (n = 55) monotherapy for 3 months. Follow-up visits were at weeks 1, 4, and 12. The primary outcome measure was physician-graded conjunctival hyperemia (scale 0 to 3) at week 12. Secondary outcomes included corneal staining (scale 0 to 3) and tear break-up time (TBUT).
  
  
  RESULTS
  There were no significant differences in mean (standard deviation [SD]) outcome measures including conjunctival hyperemia (bimatoprost: 0.48 [0.52], travoprost: 0.49 [0.52], latanoprost: 0.51 [0.54]), corneal staining (bimatoprost: 0.31 [0.49], travoprost: 0.25 [0.46], latanoprost: 0.24 [0.45]), or TBUT (bimatoprost: 9.7 s [6.1], travoprost: 9.5 s [5.8], latanoprost: 9.8 s [5.0]) among subjects at latanoprost-treated baseline (P ≥ 0.664). At week 12, there were no significant differences in conjunctival hyperemia (bimatoprost: 0.42 [0.48], travoprost: 0.46 [0.44], latanoprost: 0.44 [0.57]), corneal staining (bimatoprost: 0.31 [0.45], travoprost: 0.32 [0.48], latanoprost: 0.22 [0.30]), or TBUT (bimatoprost: 9.7 s [5.7], travoprost 9.7 s [5.0], latanoprost: 9.3 s [4.0]) among the treatment groups (P ≥ 0.379). At week 1, there was a statistically significant among-group difference in mean change from baseline in hyperemia (+0.04, bimatoprost; +0.20, travoprost; 0.00, latanoprost; P = 0.018). There were no statistically significant among-group differences in mean corneal staining, mean TBUT, or change from baseline at any visit.
  
  
  CONCLUSIONS
  Despite preservative differences, there were no significant differences in objective clinical measures of ocular surface tolerability after 3 months of treatment with bimatoprost (with 0.02% BAK), travoprost (with sofZia), and latanoprost (with 0.02% BAK).
authors.affiliation: University of Calgary, 102, 49 Richard Way SW, Calgary, AB, Canada. drcricht@telusplanet.net
authors.forename: Andrew C S
authors.initials: AC
authors.lastname: Crichton
authors.forename: Steven
authors.initials: S
authors.lastname: Vold
authors.forename: Julia M
authors.initials: JM
authors.lastname: Williams
authors.forename: David A
authors.initials: DA
authors.lastname: Hollander
mesh_terms: D000368:Aged; D000577:Amides / Q000627:therapeutic use; D001548:Benzalkonium Compounds / Q000009:adverse effects*; D000069580:Bimatoprost; D003008:Cloprostenol / Q000031:analogs & derivatives / Q000627:therapeutic use; D003229:Conjunctival Diseases / Q000139:chemically induced*; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D006940:Hyperemia / Q000139:chemically induced*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects*; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use; D011465:Prostaglandins, Synthetic / Q000627:therapeutic use*; D000069557:Travoprost
chemical_list: D000577:Amides; D001548:Benzalkonium Compounds; D011310:Preservatives, Pharmaceutical; D011461:Prostaglandins F, Synthetic; D011465:Prostaglandins, Synthetic; D003008:Cloprostenol; D000077338:Latanoprost; D000069580:Bimatoprost; D000069557:Travoprost