PT  - JOURNAL ARTICLE
AU  - D L Easty
AU  - G Nemeth-Wasmer
AU  - J-P Vounatsos
AU  - B Girard
AU  - N Besnainou
AU  - P Pouliquen
AU  - L Delval
AU  - J-F Rouland
TI  - 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
AID  - 10.1136/bjo.2005.080424
DP  - 2006 May 01
TA  - British Journal of Ophthalmology
PG  - 574--578
VI  - 90
IP  - 5
4099  - http://bjo.bmj.com/content/90/5/574.short
4100  - http://bjo.bmj.com/content/90/5/574.full
SO  - Br J Ophthalmol2006 May 01; 90
AB  - 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.