title: Fixed Combination of Travoprost and Timolol Maleate Reduces Intraocular Pressure in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: A Prospective Multicenter Open-Label Study.
abstract: BACKGROUND
  The efficacy of lowering intraocular pressure (IOP) and safety of switching to travoprost/timolol fixed combination ophthalmic solution (Duotrav(®), Alcon Laboratories, Inc., Fort Worth, TX, USA) in patients with primary open-angle glaucoma, normal tension glaucoma or ocular hypertension undergoing prostaglandin analog (PGA) monotherapy was investigated.
  
  
  METHODS
  Patients treated with travoprost, latanoprost, tafluprost, or bimatoprost for ≥3 months and requiring additional medication were switched to Duotrav without washout. Baseline IOP was calculated from measurements at two visits during PGA monotherapy. IOP reductions at 4, 8, and 12 weeks after switching to Duotrav and adverse events were assessed.
  
  
  RESULTS
  Of 162 patients enrolled, 157 patients (96.9%) with ≥4 weeks of follow-up after switching to Duotrav were analyzed. The mean IOP decreased significantly (baseline = 16.3 ± 3.1 mmHg; 4 weeks = 14.6 ± 3.1 mmHg, 8 weeks = 14.7 ± 3.3 mmHg, 12 weeks = 14.6 ± 3.2 mmHg; all P < 0.0001). When study eyes were divided into three groups according to baseline IOP (≥19 mmHg: 33 eyes, 21.0%; ≥15 to <19 mmHg: 78 eyes, 49.7%; <15 mmHg: 46 eyes, 29.3%), all groups showed significant IOP reductions (P = 0.0324 ~ P < 0.0001) after switching to Duotrav. Twenty-seven of 166 patients (16.3%) in the safety analysis experienced adverse events and 26/166 patients (15.7%) experienced adverse events, for which a relationship to Duotrav could not be ruled out. Adverse events in five patients led to treatment discontinuation (eye pruritus; eye irritation; increased blood pressure and rash; increased blurred vision; deepening of the eyelid sulcus and blepharoptosis). Twelve weeks after treatment switching, eyelash changes, blepharal pigmentation and deepening of the eyelid sulcus occurred in 42 (26.8%), 29 (18.5%), and 13 (8.3%) cases, respectively, among 157 patients with follow-up. There was no significant worsening from baseline for superficial punctate keratopathy (SPK) or conjunctival hyperemia after switching (SPK score: baseline = 0.58 ± 1.31; 12 weeks = 0.92 ± 1.76, P = 0.1819; conjunctival hyperemia score: baseline = 0.41 ± 0.64; 12 weeks = 0.49 ± 0.63, P = 0.3774).
  
  
  CONCLUSIONS
  Our findings confirm that switching to Duotrav(®) in PGA monotherapy patients shows IOP-lowering effect with minimal safety concerns.
  
  
  BACKGROUND
  Japan Association of Health Service and Alcon Japan. Ltd.
  
  
  BACKGROUND
  UMIN Clinical Trials Registry identifier, UMIN000007028.
authors.affiliation: Department of Ophthalmology, The Jikei University School of Medicine, Nishi-Shimbashi, Minato-ku, Tokyo, Japan. tnakano@jikei.ac.jp.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Nakano
authors.affiliation: Department of Ophthalmology, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Mizoue
authors.affiliation: Department of Integrative Genomics, Tohoku Medical Megabank Organization, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Fuse
authors.affiliation: Tajimi Iwase Eye Clinic, Honmachi, Tajimi, Gifu, Japan.
authors.forename: Aiko
authors.initials: A
authors.lastname: Iwase
authors.affiliation: Department of Ophthalmology, Tokyo Teishin Hospital, Fujimi, Chiyoda-ku, Tokyo, Japan.
authors.forename: Shun
authors.initials: S
authors.lastname: Matsumoto
authors.affiliation: Yoshikawa Eye Clinic, Nakamachi, Machida, Tokyo, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Yoshikawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003008:Cloprostenol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004338:Drug Combinations; D057915:Drug Substitution; D005260:Female; D005901:Glaucoma / Q000188:drug therapy; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure; D007564:Japan; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D011446:Prospective Studies; D013999:Timolol / Q000627:therapeutic use*; D014065:Tonometry, Ocular
chemical_list: D004338:Drug Combinations; C571754:Duotrav; D003008:Cloprostenol; D013999:Timolol
keywords: Adverse event; Intraocular pressure; Side effect; Switching therapy; Travoprost/timolol fixed combination