title: A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost.
abstract: OBJECTIVE
  To evaluate conjunctival hyperemia associated with bimatoprost 0.01% treatment in patients who replace latanoprost 0.005% with bimatoprost 0.01%.
  
  
  METHODS
  Randomized, double-masked, vehicle-controlled, multicenter study of patients with ocular hypertension or glaucoma whose intraocular pressure (IOP) was adequately controlled on latanoprost monotherapy. At baseline, patients discontinued latanoprost and were randomized to treatment with once-daily bimatoprost 0.01% (n = 151) or vehicle (n = 71). The primary endpoint was the peak change in macroscopic hyperemia (conjunctival hyperemia evaluated by gross visual inspection) from baseline to month 1.
  
  
  RESULTS
  Bimatoprost 0.01% was noninferior to vehicle in the mean [standard deviation] peak change from baseline macroscopic hyperemia at month 1 (0.18 [0.46] in the bimatoprost 0.01% group vs 0.02 [0.32] in the vehicle group, P = 0.009). The between-group difference was 0.15 (95% confidence interval [CI]: 0.04, 0.26), which was within the predefined margin for noninferiority of 0.5 on a hyperemia grading scale of 0 to +3. There were no statistically significant between-group differences in the percentage of patients with a ≥1-grade increase in macroscopic hyperemia from baseline. Mean IOP was decreased from baseline (-0.7 to -1.3 mm Hg) in the bimatoprost 0.01% group (P ≤ 0.002) and was increased from baseline (+3.3 to +3.6 mm Hg) in the vehicle group (P < 0.001) at month 1. There were no statistically significant between-group differences in adverse events.
  
  
  CONCLUSIONS
  Bimatoprost 0.01% was noninferior to vehicle with respect to conjunctival hyperemia in this study population. Replacement of latanoprost with bimatoprost 0.01% in patients with ocular hypertension or glaucoma can result in additional IOP reduction without clinically important hyperemia.
authors.affiliation: Glaucoma Consultants of Colorado, Denver, CO, USA. ercraven@glaucdocs.com
authors.forename: E Randy
authors.initials: ER
authors.lastname: Craven
authors.forename: Ching-Chi
authors.initials: CC
authors.lastname: Liu
authors.forename: Amy
authors.initials: A
authors.lastname: Batoosingh
authors.forename: Rhett M
authors.initials: RM
authors.lastname: Schiffman
authors.forename: Scott M
authors.initials: SM
authors.lastname: Whitcup