title: Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial.
abstract: OBJECTIVE
  The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF).
  
  
  METHODS
  A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment.
  
  
  RESULTS
  Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p < 0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF - BUDPF) was observed (p < 0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: -4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p < 0.01 for both drugs; p = 0.32 between the two drugs); -5.2 ± 0.5 and -3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p < 0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs).
  
  
  CONCLUSIONS
  This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.
authors.affiliation: Department of Ophthalmology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. ingeborg.stalmans@mac.com.
authors.forename: Ingeborg
authors.initials: I
authors.lastname: Stalmans
authors.affiliation: Glaucoma Research Unit, G.B.Bietti Eye Foundation - IRCCS, Via Livenza 3, 00198, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Oddone
authors.affiliation: ICORG - Imperial College Ophthalmologic Research Group, Western Eye Hospital, 171 Marylebone Road, London, NW1 5QH, UK.
authors.forename: Maria Francesca
authors.initials: MF
authors.lastname: Cordeiro
authors.affiliation: Hommer Ophthalmology Institute, Albertgasse 39, A-1080, Vienna, Austria.
authors.forename: Anton
authors.initials: A
authors.lastname: Hommer
authors.affiliation: Centre for Clinical Trials at San Paolo Hospital, University of Milan, via di Rudinì, 8, 20142, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Montesano
authors.affiliation: AIBILI - Association for Innovation and Biomedical Research on Light and Image, Centre for Clinical Trials, Azinhaga Santa Comba, Celas, 3000-548, Coimbra, Portugal.
authors.forename: Luisa
authors.initials: L
authors.lastname: Ribeiro
authors.affiliation: Clinical Research Center, Mèmorial A de Rotschild, 22 Chemin Beau Soleil, 1208, Geneva, Switzerland.
authors.forename: Gordana
authors.initials: G
authors.lastname: Sunaric-Mégevand
authors.affiliation: Centre for Clinical Trials at San Paolo Hospital, University of Milan, via di Rudinì, 8, 20142, Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Rossetti
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use*; D000069580:Bimatoprost / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects / Q000502:physiology; D000077338:Latanoprost; D009798:Ocular Hypertension / Q000188:drug therapy / Q000503:physiopathology; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use*; D066167:Slit Lamp; D014065:Tonometry, Ocular; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost; D000069580:Bimatoprost
keywords: Bimatoprost; Cross-over; Latanoprost; Preservative-free; Prostaglandin