title: Randomized, Controlled, Phase 3 Trials of Carteolol/Latanoprost Fixed Combination in Primary Open-Angle Glaucoma or Ocular Hypertension.
abstract: OBJECTIVE
  To assess the intraocular pressure (IOP)-lowering effects and safety of a carteolol/latanoprost fixed combination drug (OPC-1085EL) vs latanoprost (Study 1) and carteolol (Study 2) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).
  
  
  METHODS
  Multicenter, randomized, evaluator-masked (Study 1)/double-masked (Study 2), parallel-group studies.
  
  
  METHODS
  Setting: Twenty-eight clinical sites (Study 1) and 19 clinical sites (Study 2) in Japan.
  
  
  METHODS
  Outpatients with bilateral POAG or OH whose predose IOP was 18 to <35 mm Hg in the study eye after 4 weeks' treatment with latanoprost (Study 1) or carteolol (Study 2) (defined as baseline).
  
  
  METHODS
  In Study 1, 237 patients applied OPC-1085EL (n = 118) or latanoprost (n = 119) for 8 weeks. In Study 2, 193 patients applied OPC-1085EL (n = 78), carteolol (n = 78), or carteolol/latanoprost concomitant therapy (n = 37) for 8 weeks.
  
  
  METHODS
  Adjusted mean IOP reduction at predose from baseline to week 8.
  
  
  RESULTS
  In Study 1, the adjusted mean IOP reductions (95% confidence interval [CI]) were 2.9 (2.5-3.3) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and latanoprost groups, respectively (P < .0001). In Study 2, the adjusted mean IOP reductions (95% CI) were 3.5 (3.1-3.9) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and carteolol groups, respectively (P < .0001). All adverse drug reactions of OPC-1085EL observed in both studies were mild in severity and only 1 patient in each study discontinued because of an adverse drug reaction.
  
  
  CONCLUSIONS
  OPC-1085EL is superior to latanoprost or carteolol alone in terms of lowering IOP, and was well tolerated.
authors: Department of Ophthalmology, Gifu University Graduate School of Medicine, Gifu, Japan. Electronic address: mmc-gif@umin.net.
authors: Tetsuya
authors: T
authors: Yamamoto
authors: Department of Clinical Development, Otsuka Pharmaceutical Co, Ltd, Osaka, Japan.
authors: Toru
authors: T
authors: Ikegami
authors: Department of Clinical Development, Otsuka Pharmaceutical Co, Ltd, Osaka, Japan.
authors: Yuji
authors: Y
authors: Ishikawa
authors: Department of Medical Affairs, Otsuka Pharmaceutical Co, Ltd, Osaka, Japan.
authors: Satoru
authors: S
authors: Kikuchi
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage; D002354:Carteolol / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects / Q000502:physiology*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000000981:diagnostic imaging* / Q000503:physiopathology; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost; D002354:Carteolol