EXTENDED REPORT

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

D L Easty¹, G Nemeth-Wasmer², J-P Vounatsos³, B Girard⁴, N Besnainou⁵, P Pouliquen⁶, L Delval⁶ and J-F Rouland⁷

¹ Department of Ophthalmology, Bristol Eye Hospital, Lower Maudlin Street, Bristol BS1 2LX, UK
² 5 place du 2 Février, 68000 Colmar, France
³ 30 cours de l’Intendance, 33000 Bordeaux, France
⁴ 41 rue de Liège, 75008 Paris, France
⁵ 9 avenue de la République, 94700 Maisons Alfort, France
⁶ Laboratoires THEA, 12 rue Louis-Blériot, ZI du Brézet, 63017 Clermont-Ferrand Cedex 2, France
⁷ Hôpital Huriez, Aile Ouest, Service d’Ophtalmologie, Place de Verdun, 59000 Lille, France

Correspondence to:
Correspondence to:
Professor David L Easty
Department of Ophthalmology, Bristol Eye Hospital, Lower Maudlin Street, Bristol BS1 2LX, UK; david.easty{at}bristol.ac.uk

Aim: 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.

Methods: 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.

Results: 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.

Conclusion: The overall study results demonstrated that T-Gel 0.1% SDU is not inferior to T-Gel 0.1% MD.

Abbreviations: AEs, adverse events; BAK, benzalkonium chloride; BUT, break up time; IOP, intraocular pressure; LOQ, lower limit of quantification; MD, multidose; OHT, ocular hypertension; POAG, primary open angle glaucoma; SDU, single dose unit; VA, visual acuity

Keywords: intraocular pressure; primary open angle glaucoma; ocular hypertension; timolol gel

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