title: Bimatoprost 0.01% vs bimatoprost 0.03%: a 12-month prospective trial of clinical and in vivo confocal microscopy in glaucoma patients.
abstract: OBJECTIVE
  To evaluate the safety of two commercially available formulations of bimatoprost eye drops: 0.03 and 0.01% ophthalmic solutions.
  
  
  METHODS
  This was a randomized, prospective, parallel-group, open-label, cohort study. A total of 60 glaucoma patients (60 eyes) under bimatoprost 0.03% monotherapy since at least 1 year were enrolled. Selected patients were randomized to receive a single drop of bimatoprost 0.01% (n=30) or bimatoprost 0.03% (n=30) ophthalmic solutions for 12 months. Statistical analysis was performed using paired t-test and repeated measures ANOVA test.
  
  
  RESULTS
  Global clinical score (the sum of pruritus, stinging/burning, blurred vision, sticky eye sensation, eye dryness sensation, and foreign body sensation) significantly decreased in the bimatoprost 0.01% group from baseline 4.7 ± 3.8 to 2.9 ± 2.3 (P < 0.001) and 2.5 ± 2.0 (P < 0.001) at 6-month and 12-month follow-ups, respectively. Comparison between groups showed differences at both follow-up visits (P = 0.003 and P < 0.001, respectively). In vivo confocal microscopy revealed a significant increase in goblet cell density in the bimatoprost 0.01% group compared with the bimatoprost 0.03% group (P<0.001 at both follow-up visits). All functional parameters and conjunctival hyperemia improved in the bimatoprost 0.01% group at each follow-up visit (P < 0.05) and in comparison with bimatoprost 0.03% (P < 0.05).
  
  
  CONCLUSIONS
  The results of this trial suggest that bimatoprost 0.01% eye drops seem to decrease the ocular discomfort with respect to bimatoprost 0.03% eye drops.
authors.affiliation: Ophthalmology Unit, Department of Surgical, Medical and Molecular Pathology, and Critical Area, University of Pisa, Pisa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Figus
authors.affiliation: Ophthalmology Unit, Department of Surgical, Medical and Molecular Pathology, and Critical Area, University of Pisa, Pisa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Nardi
authors.affiliation: Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Piaggi
authors.affiliation: Ophthalmology Unit, Department of Surgical, Medical and Molecular Pathology, and Critical Area, University of Pisa, Pisa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Sartini
authors.affiliation: Ophthalmology Unit, Department of Surgical, Medical and Molecular Pathology, and Critical Area, University of Pisa, Pisa, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Guidi
authors.affiliation: Ophthalmology Unit, Department of Surgical, Medical and Molecular Pathology, and Critical Area, University of Pisa, Pisa, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Martini
authors.affiliation: Ophthalmology Unit, Department of Surgical, Medical and Molecular Pathology, and Critical Area, University of Pisa, Pisa, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Lazzeri
mesh_terms: D000577:Amides / Q000009:adverse effects / Q000627:therapeutic use*; D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069580:Bimatoprost; D003008:Cloprostenol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D058447:Eye Pain / Q000175:diagnosis; D005901:Glaucoma / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D018613:Microscopy, Confocal; D008875:Middle Aged; D011446:Prospective Studies; D013666:Tears / Q000187:drug effects / Q000378:metabolism; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D003008:Cloprostenol; D000069580:Bimatoprost