title: Effect of benzalkonium chloride-free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study.
abstract: BACKGROUND
  Prostaglandin analogs reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; however, these medications may affect the ocular surface and elicit ocular discomfort when preserved with benzalkonium chloride (BAK).
  
  
  METHODS
  This was an open-label, single-arm study conducted in Latin America from February 2012 to May 2013. Patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost 0.005 % were transitioned to receive once-daily BAK-free travoprost 0.004 % containing polyquaternium-1 (Travatan® preserved with POLYQUAD® [PQ], Alcon Laboratories, Inc; Fort Worth, TX) for 12 weeks. Mean change in IOP from baseline (primary efficacy endpoint) and the percentage of patients who achieved a target IOP of ≤18 mmHg were evaluated at all on-therapy visits. Ocular hyperemia, patient preference, and self-projected adherence were assessed at week 12. Adverse events (AEs) were monitored throughout the study.
  
  
  RESULTS
  All enrolled patients were included in the analysis (n = 191); the majority of patients (90.6 %, n = 173/191) completed the study. Mean (SD) patient age was 67.5 (11.3) years, and mean baseline IOP was 14.8 mmHg. Mean IOP was reduced by 0.94 mmHg at week 6 and by 1.09 mmHg at week 12 (P < 0.001 for both). A greater percentage of patients achieved a target IOP of ≤18 mmHg at week 6 (93.1 %; n = 163/175) and week 12 (93.3 %; n = 166/178) compared with baseline (89.5 %; n = 171/191). There was a 10.5 % increase in the percentage of patients with "none/trace" amounts of hyperemia. Most patients preferred the study medication (81.5 %; n = 141/173) and were confident that they would adhere to their preferred medication (90.8 %; n = 157/173). No serious AEs were reported, and eye irritation (3.7 %; n = 7/191) was the most common treatment-related AE.
  
  
  CONCLUSIONS
  Transitioning from BAK-containing latanoprost 0.005 % to BAK-free travoprost 0.004 % preserved with PQ reduced IOP in patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost. BAK-free travoprost 0.004 % is a viable alternative for patients who require switching their IOP-lowering medications because of tolerability issues.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier, NCT01510145.
authors.affiliation: Clinica Oftalmológica Pasteur, Luis Pasteur 5917 - Vitacura, Santiago, Chile. lopesjf@gmail.com.
authors.forename: Joao F
authors.initials: JF
authors.lastname: Lopes
authors.affiliation: Alcon Laboratories, Inc., Fort Worth, TX, USA. doug.hubatsch@alcon.com.
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Hubatsch
authors.affiliation: Clínica Oftalmológica del Caribe, Barranquilla, Colombia. patamaris@gmail.com.
authors.forename: Patricia
authors.initials: P
authors.lastname: Amaris
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001548:Benzalkonium Compounds; D003229:Conjunctival Diseases / Q000139:chemically induced; D003316:Corneal Diseases / Q000139:chemically induced; D057915:Drug Substitution; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D006940:Hyperemia / Q000139:chemically induced; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D011310:Preservatives, Pharmaceutical; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use*; D014065:Tonometry, Ocular; D000069557:Travoprost / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D001548:Benzalkonium Compounds; D011310:Preservatives, Pharmaceutical; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost; D000069557:Travoprost