title: 24-hour efficacy of travoprost/timolol BAK-free versus latanoprost/timolol fixed combinations in patients insufficiently controlled with latanoprost.
abstract: BACKGROUND
  To compare the 24-h intraocular pressure (IOP) control and tolerability of travoprost/timolol benzalkonium chloride (BAK)-free (TTFC) vs. latanoprost/timolol fixed combination preserved with BAK (LTFC) in open-angle glaucoma patients insufficiently controlled with latanoprost 0.005% monotherapy given once in the evening.
  
  
  METHODS
  The authors have conducted a prospective, observer-masked, active-controlled, cross-over, comparison study. Qualified open-angle glaucoma patients who demonstrated a latanoprost-treated morning IOP (10:00 ± 1 h) greater than 20 mmHg on two separate visits were randomized for 3 months to receive either TTFC or LTFC. Patients were then crossed over to the opposite treatment for another 3 months. At the end of the latanoprost run-in and after each 3-month therapy period patients underwent 24-h IOP monitoring in the habitual position using Goldmann applanation tonometry in the sitting position during the day (10:00, 14:00, 18:00 and 22:00) and Perkins tonometry in the supine position at night (02:00 and 06:00). Selected ocular surface parameters were evaluated after each therapy period.
  
  
  RESULTS
  Forty-two open-angle glaucoma patients completed the study. The mean 24-h baseline IOP on latanoprost was 21.5 ± 1.6 mmHg. Both fixed combinations significantly reduced the IOP at each time point, for the mean, peak and fluctuation of 24-h IOP compared with latanoprost monotherapy (P < 0.01). When the two fixed combinations were compared directly, TTFC provided significantly lower mean 24-h IOP (18.9 ± 2.2 mmHg) vs. LTFC (19.3 ± 2.3 mmHg) (P = 0.004) and significantly lower IOP at 18:00 (18.6 ± 2.5 vs. 19.5 ± 2.7 mmHg for LTFC) (P < 0.001). Further, TTFC demonstrated significantly better tear film break-up time (5.15 vs. 4.65 s), corneal stain (1.5 vs. 1.8) and Schirmer I test (9.9 vs. 9.2 mm) compared with LTFC after 3 months of therapy (P < 0.01 for all comparisons).
  
  
  CONCLUSIONS
  The mean 24-h IOP lowering of TTFC was statistically more significant compared to LTFC in patients insufficiently controlled with latanoprost monotherapy. Measurement of ocular surface health and tear film status favored the BAK-free TTFC compared to LTFC.
authors.affiliation: 1st University Department of Ophthalmology, Aristotle University of Thessaloniki, 1 Kyriakidi Street, 546 36, Thessaloniki, Greece, konstas@med.auth.gr.
authors.forename: Anastasios G P
authors.initials: AG
authors.lastname: Konstas
authors.forename: Irini C
authors.initials: IC
authors.lastname: Voudouragkaki
authors.forename: Kostantinos G
authors.initials: KG
authors.lastname: Boboridis
authors.forename: Anna-Bettina
authors.initials: AB
authors.lastname: Haidich
authors.forename: Eleni
authors.initials: E
authors.lastname: Paschalinou
authors.forename: Theodoros
authors.initials: T
authors.lastname: Giannopoulos
authors.forename: Nikolaos D
authors.initials: ND
authors.lastname: Dragoumis
authors.forename: Alexandros K
authors.initials: AK
authors.lastname: Makridis
authors.forename: Malik Y
authors.initials: MY
authors.lastname: Kahook
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects; D018592:Cross-Over Studies; D004338:Drug Combinations; D016903:Drug Monitoring / Q000379:methods; D004357:Drug Synergism; D005260:Female; D005902:Glaucoma, Open-Angle / Q000175:diagnosis / Q000188:drug therapy; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage / Q000009:adverse effects; D013999:Timolol / Q000008:administration & dosage / Q000009:adverse effects; D014065:Tonometry, Ocular / Q000379:methods; D000069557:Travoprost / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D018696:Neuroprotective Agents; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost; D013999:Timolol; D000069557:Travoprost