title: Safety and efficacy of monotherapy change to fixed combination (travoprost 0.004%/timolol 0.5%) in 6 months follow up period.
abstract: OBJECTIVE
  To assess the safety and efficacy of changing antiglaucoma therapy to the travoprost 0.004%/timolol 0.5% (TTFC) fixed combination from previous monotherapies.
  
  
  METHODS
  Prospective, open-label, observational, multicenter cohort. A change was done from prior monotherapy at day 0 to TTFC dosed once a day, regardless in the evening or in the morning, without washout period. Active evaluation of systemic and local tolerability (adverse events), and efficacy. i.e., intraocular pressure (IOP) lowering was done at control 1 (day 30), control 2 (day 90) and control 3 (day 120).
  
  
  RESULTS
  40/155/170 patients (79/309/339 eyes) completed the study (120 days/ 90 days/baseline, respectfully). At control 1 excluded were patients with low tolerability (severe hyperemia (6 patients), discomfort (4), chest pain (1)) and non responders (IOP lowering less than 15% from baseline IOP or target IOP >18 mmHg (4 patients)). Mean IOP at control 1 was 15.92 +/- 1.85 mm Hg (21.66% reduction) for 155 patients (non responders excluded), at control 2 was for 155 patients 15.67 +/- 2.17 mm Hg (21.14% reduction), and at control 3 for 40 patients 16.28 +/- 1.59 mm Hg (19.86% reduction). At control 2 analysis of IOP reduction by 4 groups of previous monotherapy (timolol 0,5% (N = 33/66), latanoprost 0.005% (N = 49/98), betaxolol 0.5% (N = 30/60), and travoprost 0.004% (N = 43/85) was performed. 40 patients/79 eyes endured to control 3 (after day 90 free samples were not available for all patients). Analysis of IOP reduction by 4 groups of previous monotherapy medications was performed (timolol 0.5% (N = 7/14), latanoprost 0.005% (N = 14/28), betaxolol 0.5% (N = 7/14), travoprost 0.004% (N = 12/23)).
  
  
  CONCLUSIONS
  Changing patients from prior monotherapy to TTFC can provide on average a further reduction in IOP, while demonstrating a favorable safety profile.
authors.affiliation: Department of ophthalmology, Clinical Department of Ophthalmology Hospital Sisters of Charity, Refferal Center for Glaucoma, Ministry of Health and Welfare of Republic of Croatia, Zagreb.
authors.forename: Zdravko
authors.initials: Z
authors.lastname: Mandić
authors.forename: Katia
authors.initials: K
authors.lastname: Novak-Laus
authors.forename: Lovro
authors.initials: L
authors.lastname: Bojić
authors.forename: Smiljka
authors.initials: S
authors.lastname: Popović-Suić
authors.forename: Miroslav
authors.initials: M
authors.lastname: Ekert
authors.forename: Vukosava Maricić
authors.initials: VM
authors.lastname: Dosen
authors.forename: Goran
authors.initials: G
authors.lastname: Pelcić
authors.forename: Damira
authors.initials: D
authors.lastname: Clementi
authors.forename: Davor
authors.initials: D
authors.lastname: Dobutović
authors.forename: Dubravka
authors.initials: D
authors.lastname: Biuk
authors.forename: Renata
authors.initials: R
authors.lastname: Iveković
authors.forename: Zeljko
authors.initials: Z
authors.lastname: Kovacić
authors.forename: Josip
authors.initials: J
authors.lastname: Pavan
authors.forename: Nikola
authors.initials: N
authors.lastname: Susić
authors.forename: Mia Zorić
authors.initials: MZ
authors.lastname: Geser
authors.forename: Iva
authors.initials: I
authors.lastname: Krolo
authors.forename: Freja
authors.initials: F
authors.lastname: Barisić
authors.forename: Alenka
authors.initials: A
authors.lastname: Jurić-Miletić
authors.forename: Katarina Kapeli
authors.initials: KK
authors.lastname: Dogan
authors.forename: Martina
authors.initials: M
authors.lastname: Tomić
authors.forename: Suzana
authors.initials: S
authors.lastname: Kovacević
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage*; D003008:Cloprostenol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004338:Drug Combinations; D057915:Drug Substitution; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D009798:Ocular Hypertension / Q000188:drug therapy; D013999:Timolol / Q000008:administration & dosage* / Q000009:adverse effects; D000069557:Travoprost
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D003008:Cloprostenol; D013999:Timolol; D000069557:Travoprost