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Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma
  1. Jean-François Rouland1,
  2. Carlo Enrico Traverso2,
  3. Ingeborg Stalmans3,
  4. Lamia El Fekih4,
  5. Laurent Delval5,
  6. Didier Renault5,
  7. Christophe Baudouin6,
  8. for the T2345 Study Group
  1. 1Service Ophtalmologie, CHRU de Lille, Lille, France
  2. 2Clinica Oculistica, Università di Genova, Azienda Ospedaliero Universitaria San Martino Viale Benedetto XV, Genova, Italia
  3. 3Ophthalmology Department, University Hospitals Leuven, Leuven, Belgium
  4. 4Université de Tunis El Manar, Faculté de Médecine de Tunis, 1007 Tunis, Tunisie; Hôpital des F.S.I., Service Ophtalmologie, rue Tahar Ben Achour, La Marsa, Tunis, Tunisie
  5. 5Service Direction Médicale, Laboratoires Théa, Clermont-Ferrand, France
  6. 6Department of Ophthalmology III, Quinze-Vingts National Ophthalmology Hospital and Vision Institute, University Paris 6, Paris, France
  1. Correspondence to Professor Jean-François Rouland, Service ophtalmologie, CHRU de Lille, Place de Verdun, Lille 59000, France; jfr3{at}wanadoo.fr

Abstract

Aim To compare efficacy (intraocular pressure (IOP) reduction) and safety of preservative-free latanoprost (T2345) to benzalkonium chloride (BAK)-preserved latanoprost (BPL; Xalatan) in ocular hypertension (OHT) or primary open angle glaucoma (POAG) patients.

Methods Prospective, international, multicentre, randomised, investigator-masked, parallel–group trial. After a wash-out period, POAG or OHT patients, previously managed by BPL monotherapy, randomly received T2345 or BPL (one drop into the affected eye(s)) once daily from D0 to D84. Change in IOP was measured at 09:00 (±1 h) from D0 to D84 in the worse eye.

Results Mean IOP reduction (D0–D84) was −8.6±2.6 mm Hg (−36%) on T2345 and −9.0±2.4 mm Hg (−38%) on BPL, confirming non-inferiority of T2345 to BPL. Non-inferiority of T2345 was observed from D15. The most frequent ocular adverse event, drug intolerance, was reported in 1 (0.5%) patient on T2345 versus 4 (2.1%) patients on BPL. Moderate to severe conjunctival hyperaemia was less frequent on T2345 than on BPL at D42 (20.2% vs 30.6%; p=0.003) and D84 (21.4% vs 29.1%; p=0.02). Upon instillation, the global subjective ocular symptom score was significantly lower on T2345 than BPL on D42 (0.15 vs 0.41; p=0.001) and D84 (0.18 vs 0.46; p=0.001).

Conclusions Preservative-free latanoprost has the same efficacy as BPL, with improved local tolerance.

  • Intraocular Pressure
  • Glaucoma

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