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001-es BibID:	BIBFORM078110
035-os BibID:	(PMID)30921274
Első szerző:	Aptel, Florent
Cím:	Noninferiority of Preservative-free versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients with Open-angle Glaucoma or Ocular Hypertension / Florent Aptel, Norbert Pfeiffer, Stefanie Schmickler, Jonathan Clarke, Cosme Lavín-Dapena, Javier Moreno-Montañés, Tomasz Żarnowski, Adrienne Csutak, Tiia Jugaste, Lāsma Volksone, Yury S. Astakhov, Laurent Coupier, Jean-Philippe Nordmann, Ingeborg Stalmans, T2347 Study Group
Dátum:	2019
ISSN:	1057-0829
Megjegyzések:	Purpose: To compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension. Methods: Phase III,randomizedd, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged ?18 years with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7?2.4 mm Hg overall prior to inclusion) were randomised at Day 0 with no washout period to receive the preservative-free alternative T2347 (N=127) or remain on the preserved comparator (N=115) for 84 days. Intraocular pressure changes from Day 0 were measured at 9:00 am (+/- 1 hour) on Day 42 and Day 84, and non-inferiority of T2347 to the preserved comparator wasanalyzedd statistically at Day 84. Safety parameters were also reported. Results: The mean change in intraocular pressure from baseline to Day 84 was -0.49?1.80 mm Hg for preservative-free T2347 and -0.49?2.25 mm Hg for the preserved comparator. These results met the non-inferiority limits. Similar results were observed at Day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at Day 84 (45.9%/44.3%/9.8% patients with improvement/no change/worsening versus 33.6%/47.3%/19.1%; p=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (p<0.001) and itching (p<0.01) on Day 84. Conclusion: Preservative-free latanoprost-timolol fixed combination T2347 showed noninferior efficacy compared to the preserved comparator and was well tolerated.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban glaucoma ocular hypertension preservative-free latanoprost-timolol
Megjelenés:	Journal Of Glaucoma. - 28 : 6 (2019), p. 498-506. -
További szerzők:	Pfeiffer Norbert Schmickler, Stefanie Clarke, Jonathan Lavín-Dapena, Cosme Moreno-Montañés, Javier Żarnowski, Tomasz Csutak Adrienne (1971-) (szemész) Jugaste, Tiia Volksone, Lāsma Astakhov, Yury S. Coupier, Laurent Nordmann, Jean-Philippe Stalmans, Ingeborg T2347 Study Group
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