title: A 1-year randomized study of the clinical and confocal effects of tafluprost and latanoprost in newly diagnosed glaucoma patients.
abstract: BACKGROUND
  The aim of the present study was to compare the confocal and clinical features of newly diagnosed glaucoma patients receiving unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost).
  
  
  METHODS
  40 patients were randomized to tafluprost 0.0015% (20 patients; 32 eyes) or latanoprost 0.005% + benzalkonium chloride 0.02% (20 patients; 35 eyes) once daily for 1 year. Inclusion criteria were new glaucoma diagnosis, and no ocular treatments for 6 months before the study. Patients were evaluated at baseline and every 3 months with a complete ophthalmologic evaluation, Schirmer's test, break-up time test, confocal microscopy of the central cornea, and measurement of intraocular pressure (IOP). Investigators were masked to treatment. Both eyes were analyzed if they fulfilled inclusion criteria. Treatments and changes between follow-up and baseline were compared by analysis of variance (ANOVA), t test and Chi-square test.
  
  
  RESULTS
  At baseline, the two groups had similar age, ocular surface and confocal findings; keratocyte activation was present in 40%, branching pattern in 85%, and beading in 75%, with no inter-group differences. At follow-up, no significant clinical changes were detected, apart from a drop of IOP by 3.6-4.2 mmHg in the two groups (p < 0.001, with no difference between treatments). Despite inter-treatment ANOVA for confocal microscopy being negative, subtle changes were present. During follow-up, all eyes without nerve branching pattern at baseline progressively developed it when treated with latanoprost, whereas no change occurred using tafluprost treatment (p = 0.05). None of the eyes without beading at baseline developed it at the end of the study in the tafluprost group, whereas beading did occur in 75% of patients treated with latanoprost (p = 0.05). Both treatments were associated with increased keratocyte activation at follow-up; the change from baseline was statistically significant after month 3 with latanoprost (p = 0.02) and after month 6 with tafluprost (p = 0.04).
  
  
  CONCLUSIONS
  The two study treatments had similar clinical effects, but tafluprost had a more favorable profile for some confocal parameters of the cornea.
  
  
  BACKGROUND
  Merck Sharp & Dohme International.
authors.affiliation: Eye Clinic, Dipartimento Testa-Collo, Ospedale San Paolo, University of Milan, Milan, Italy, fogagnolopaolo@googlemail.com.
authors.forename: Paolo
authors.initials: P
authors.lastname: Fogagnolo
authors.forename: Angelica
authors.initials: A
authors.lastname: Dipinto
authors.forename: Elisa
authors.initials: E
authors.lastname: Vanzulli
authors.forename: Emanuele
authors.initials: E
authors.lastname: Maggiolo
authors.forename: Stefano
authors.initials: S
authors.lastname: De Cilla'
authors.forename: Alessandro
authors.initials: A
authors.lastname: Autelitano
authors.forename: Luca
authors.initials: L
authors.lastname: Rossetti
mesh_terms: D060433:Administration, Ophthalmic; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D003315:Cornea; D005260:Female; D005901:Glaucoma / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011460:Prostaglandins F / Q000627:therapeutic use*; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use*
chemical_list: D000959:Antihypertensive Agents; D011460:Prostaglandins F; D011461:Prostaglandins F, Synthetic; C485333:tafluprost; D000077338:Latanoprost