June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Efficacy and safety of a new preservative-free fixed combination latanoprost-timolol (T2347) for open-angle glaucoma or ocular hypertension
Author Affiliations & Notes
  • Jonathan C Clarke
    Glaucoma, Moorfields Eye Hospital, London, United Kingdom
  • Cosme Lavin-Dapena
    Servicio de Oftalmología, Hospital La Paz, Madrid, Spain
  • Tomasz Zarnowski
    SPSK, LUBLIN, Poland
  • Norbert Pfeiffer
    University Medical Center, Mainz, Germany
  • Jean Philippe Nordmann
    OPHTHALMOLOGY, CHNO des Quinze-Vingts, PARIS, France
  • Ingeborg Stalmans
    Glaucoma Unit, University Hospitals, LEUVEN, Belgium
  • Footnotes
    Commercial Relationships   Jonathan Clarke, Laboratoires THEA (R); Cosme Lavin-Dapena , LABORATOIRES THEA (R); Tomasz Zarnowski, LABORATOIRES THEA (R); Norbert Pfeiffer, Laboratoires THEA (R); Jean Philippe Nordmann, Laboratoires THEA (R); Ingeborg Stalmans, Laboratoires THEA (R)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2102. doi:
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      Jonathan C Clarke, Cosme Lavin-Dapena, Tomasz Zarnowski, Norbert Pfeiffer, Jean Philippe Nordmann, Ingeborg Stalmans; Efficacy and safety of a new preservative-free fixed combination latanoprost-timolol (T2347) for open-angle glaucoma or ocular hypertension. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2102.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To compare the effect on IOP and safety of unpreserved fixed combination latanoprost-timolol (T2347) to established benzalkonium chloride (BAK)-preserved latanoprost-timolol (BPLT, Xalacom®) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).

Methods : Phase III, randomised, parallel-group, investigator-masked study conducted in 10 countries. Male or female patients aged ≥18 years with OAG or OHT in both eyes controlled with BPLT were randomised at Day 0 (D0) to receive T2347 (N=127) or BPLT (N=115) each evening for 84 days. Efficacy on intraocular pressure (IOP) was measured in the morning of D0, D42, and D84, and non-inferiority of T2347 to BPLT was tested statistically based on the change in IOP from D0 to D84. Safety parameters were also reported.

Results : The mean change in IOP from baseline to D84 was -0.49±1.80 mmHg for preservative-free T2347 and -0.49±2.25 mmHg for preserved BPLT. These results met the limits set for non-inferiority. Similar results were observed at D42. T2347 was better tolerated than BPLT in terms of ocular irritation/burning/stinging on instillation on D42 (p=0.003) and D84 (p<0.001), and itching on D84 (p=0.010). Itching throughout the day was also less severe for T2347 than BPLT on D84 (p<0.001).

Conclusions : Preservative-free fixed combination latanoprost-timolol formulation showed similar efficacy and better tolerability than BPLT, suggestive of a therapeutic advantage of the preservative-free formulation for chronic use in patients with OAG/OHT.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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