title: Comparison of the Effects of Dorzolamide/Timolol Fixed Combination versus Latanoprost on Intraocular Pressure and Ocular Perfusion Pressure in Patients with Normal-Tension Glaucoma: A Randomized, Crossover Clinical Trial.
abstract: BACKGROUND
  To assess the noninferiority of a dorzolamide-timolol fixed combination (DTFC) versus latanoprost in terms of intraocular pressure (IOP) and to compare blood pressure (BP), ocular perfusion pressure (OPP) and diastolic ocular perfusion pressure (DOPP) between the latanoprost and DTFC groups in patients with normal-tension glaucoma (NTG).
  
  
  METHODS
  Prospective, interventional, randomized, single-blinded, crossover design study. Patients with newly diagnosed NTG that had not been treated with a glaucoma medication in the most recent 2 months were recruited. In total, 44 patients with NTG were randomly allocated to one of two groups. Patients in group A were treated with DTFC, lubricant, and latanoprost for 4 weeks each, whereas patients in group B were treated with latanoprost, lubricant, and DTFC for 4 weeks each. Patients were examined on day 1 (without medication), week 4 (under medication), week 8 (without medication), and week 12 (under medication). At weeks 4 and 12, diurnal IOP, systolic and diastolic BP, and OPP were measured at 8:00 AM, 10:00 AM, 12:00 PM, 4:00 PM, and 8:00 PM.
  
  
  RESULTS
  Baseline demographic characteristics showed no difference in terms of age, sex, central corneal thickness, spherical equivalent, or stage of glaucoma between the groups. The between-group difference was -0.19 ± 0.18 mmHg (mean ± SE, upper bound of one-sided 95% CI, 0.12). Diurnal IOP showed no difference between the groups with an average IOP reduction of 13.1% using latanoprost and 12.3% using DTFC. Diurnal systolic and diastolic BP were lower in the DTFC group than the latanoprost group; however, the difference between the groups was not statistically significant. Diurnal OPP and DOPP also showed no statistically significant difference between the groups.
  
  
  CONCLUSIONS
  IOP lowering efficacy of DTFC was noninferior to that of latanoprost in newly diagnosed NTG patients. There was no difference in BP, OPP, or DOPP between the latanoprost and DTFC groups. This prospective, randomized, single-blinded, crossover study demonstrated the noninferiority of DTFC versus latanoprost in terms of IOP in patients with NTG.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01175902.
authors.affiliation: Department of Ophthalmology and Visual Science, College of Medicine, Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Korea.
authors.forename: Na Young
authors.initials: NY
authors.lastname: Lee
authors.affiliation: Department of Ophthalmology and Visual Science, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
authors.forename: Hae-Young Lopilly
authors.initials: HY
authors.lastname: Park
authors.affiliation: Department of Ophthalmology and Visual Science, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
authors.forename: Chan Kee
authors.initials: CK
authors.lastname: Park
mesh_terms: D001794:Blood Pressure / Q000187:drug effects; D002940:Circadian Rhythm / Q000187:drug effects; D018592:Cross-Over Studies; D003710:Demography; D003971:Diastole / Q000187:drug effects; D004338:Drug Combinations; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D000077338:Latanoprost; D057066:Low Tension Glaucoma / Q000188:drug therapy* / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D010477:Perfusion; D011461:Prostaglandins F, Synthetic / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013449:Sulfonamides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013599:Systole / Q000187:drug effects; D013876:Thiophenes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013999:Timolol / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; D011461:Prostaglandins F, Synthetic; D013449:Sulfonamides; D013876:Thiophenes; C479140:dorzolamide-timolol combination; D000077338:Latanoprost; D013999:Timolol