Comparison of a non-preserved 0.1% T-Gel eye gel (single dose unit) with a preserved 0.1% T-Gel eye gel (multidose) in ocular hypertension and glaucomatous patients.

The British Journal of Ophthalmology
D L EastyJ-F Rouland

Abstract

This comparative, open design, phase III study was to assess the non-inferiority of the non-preserved T-Gel 0.1% single dose unit (SDU) versus its preserved multidose (MD) reference. 175 patients with bilateral POAG or OHT were randomised: 87 patients were to receive one drop daily of T-Gel 0.1% MD and 88 patients were to receive one drop daily of T-Gel 0.1% SDU, for a treatment period of 12 weeks. The primary efficacy variable was the change in intraocular pressure (IOP) in the worse eye between the baseline and the last assessment. Subjective and objective ocular signs as well as adverse events were recorded for safety. Global tolerance was assessed by the investigator and by the patient. The mean percentage reduction from baseline IOP was 24% for both treatments groups, which was consistent with previous studies. The safety results were comparable in both treatment groups. Because of gel formulation, mild short lasting episodes of blurred vision occurred for about 20% of patients. The global tolerance assessment reported that both treatments were well tolerated. The overall study results demonstrated that T-Gel 0.1% SDU is not inferior to T-Gel 0.1% MD.

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Citations

Feb 11, 2014·Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics·Minako KaidoKazuo Tsubota
Sep 13, 2011·Expert Opinion on Drug Delivery·Maurizio RolandoMalik Y Kahook
Mar 17, 2011·Expert Opinion on Emerging Drugs·Alessandro BagnisCarlo E Traverso
May 4, 2011·Expert Opinion on Investigational Drugs·Paolo Fogagnolo, Luca Rossetti
Mar 23, 2010·Progress in Retinal and Eye Research·Christophe BaudouinFrançoise Brignole-Baudouin
Oct 31, 2008·Acta Ophthalmologica. Supplement·John Thygesen
Feb 22, 2011·Chemistry, an Asian Journal·Masamichi YamanakaSachiyo Yamamichi
Nov 13, 2013·The British Journal of Ophthalmology·Murat IrkecMehmet Cem Mocan
Sep 11, 2018·Eye & Contact Lens·Xuemin ZhangOsamah Saeedi
Oct 1, 2011·Saudi Journal of Ophthalmology : Official Journal of the Saudi Ophthalmological Society·Alessandro BagnisCarlo E Traverso
Dec 15, 2011·European Journal of Ophthalmology·Teresa RolleFederico M Grignolo
Jun 14, 2019·Journal of Ophthalmology·Letizia NegriMichele Iester
Sep 1, 2012·Journal of Current Glaucoma Practice·Y Louati, T Shaarawy

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