title: Ocular hypotensive efficacy and safety of travoprost 0.004% in inadequately controlled primary open-angle glaucoma or ocular hypertension: short-term, multicenter, prospective study.
abstract: OBJECTIVE
  To evaluate the intraocular pressure (IOP) lowering efficacy and safety of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension, poorly controlled with or intolerance to beta-blockers. To record the short-term effect on diastolic ocular perfusion pressure (DOPP).
  
  
  METHODS
  One hundred and three patients with open-angle glaucoma or ocular hypertension were treated with travoprost 0.004% once daily for 90 days in an open-label, non-controlled study. Efficacy and safety were assessed at baseline, after 45 and 90 days. Clinical registry number IT0301.
  
  
  METHODS
  The primary outcome measure, IOP, was recorded at 10 am, 12 pm, and 4 pm at each visit. DOPP was evaluated at 10 am, at baseline and visit 3. Safety measures included adverse events, biomicroscopy, visual acuity, heart rate, and blood pressure.
  
  
  RESULTS
  Mean IOP was reduced from 22.2 +/- 1.7 mmHg to 16.5 +/- 2.1 after 45 days (p < 0.0001), and to 16.1 +/- 2.2 after 90 days (p < 0.0001). The DOPP increased by 5.3 +/- 6.3 mmHg after 90 days of treatment (p < 0.0001). No drug related serious adverse events were reported during the study.
  
  
  CONCLUSIONS
  The open-label and non-comparative nature of the study represented its principal limitations. The study confirmed the efficacy and tolerability of travoprost in the treatment of open-angle glaucoma or ocular hypertension, in a subset of patients unsuccessfully treated with beta-blockers. In this study, travoprost significantly increased DOPP at short-term follow-up. Further studies to assess the effect of travoprost on DOPP are warranted.
authors.affiliation: Clinica oculistica, Università di Milano, Ospedale Sacco, Milano, Italy.
authors.forename: Mirella
authors.initials: M
authors.lastname: Blini
authors.forename: Gemma Caterina Maria
authors.initials: GC
authors.lastname: Rossi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Trabucchi
authors.forename: Maria R
authors.initials: MR
authors.lastname: Curatola
authors.forename: Alessandro
authors.initials: A
authors.lastname: David
authors.forename: Rosella
authors.initials: R
authors.lastname: Radaelli
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Merlo
authors.forename: Roberto
authors.initials: R
authors.lastname: Ratiglia
mesh_terms: D000368:Aged; D003008:Cloprostenol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D000069557:Travoprost; D016896:Treatment Outcome
chemical_list: D003008:Cloprostenol; D000069557:Travoprost