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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma
British Journal of Ophthalmology, Volume 97, No. 2, Year 2013
Notification
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Description
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. © Br J Ophthalmol 2013.
Authors & Co-Authors
Rouland, Jean François
France, Lille
Chu Lille
Traverso, Carlo Enrico
Italy, Genoa
Irccs San Martino Polyclinic Hospital
Stalmans, Ingeborg
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Fekih, Lamia El
Tunisia, Tunis
Faculté de Médecine de Tunis
Tunisia, Tunis
Fsi
Delval, Laurent
France, Clermont-ferrand
Laboratoires Théa
Renault, Didier
France, Clermont-ferrand
Laboratoires Théa
Baudouin, Christophe
France, Paris
Centre Hospitalier National D‘ophtalmologie Des Quinze-vingts
Statistics
Citations: 90
Authors: 7
Affiliations: 7
Identifiers
Doi:
10.1136/bjophthalmol-2012-302121
ISSN:
00071161
e-ISSN:
14682079
Research Areas
Health System And Policy
Noncommunicable Diseases
Study Design
Cohort Study