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Abstract #80754 Published in IGR 20-3
Non-inferiority of Preservative-free versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients with Open-angle Glaucoma or Ocular Hypertension
Aptel F; Pfeiffer N; Schmickler S; Clarke J; Lavín-Dapena C; Lavín-Dapena C; Moreno-Montañés J; Żarnowski T; Csutak A; Jugaste T; Jugaste T; Volksone L; Astakhov YS; Coupier L; Coupier L; Nordmann JP; Stalmans I;Journal of Glaucoma 2019; 0:
PRECIS: Non-inferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared to a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension. 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 non-inferior efficacy compared to the preserved comparator and was well tolerated.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/.
CHU de Grenoble/University Hospital of Grenoble, Université Grenoble Alpes, Grenoble, France.
Full articleClassification:
11.16 Vehicles, delivery systems, pharmacokinetics, formulation (Part of: 11 Medical treatment)
11.13.4 Betablocker and prostaglandin (Part of: 11 Medical treatment > 11.13 Combination therapy)
