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Abstract #8088 Published in IGR 4-3
Timolol 0.1% gel (Nyogel® 0.1%) once daily versus conventional timolol 0.5% solution twice daily: a comparison of efficacy and safety
Rouland JF; Morel-Mandrino P; Elena PP; Polzer H; Sunder Raj POphthalmologica 2002; 216: 449-454
In a prospective, randomized, double-masked, parallel-group, multi-center study, 210 patients with primary open-angle glaucoma or ocular hypertension were enrolled, of whom 167 (timolol 0.1% gel 82, timolol 0.5% 85) completed the study as per protocol. The change in intraocular pressure (IOP) between baseline and week 12 in the worse eye ('at trough') was 6.3 (SD 3.3) mmHg on timolol 0.1% gel and 7.0 (2.9) mmHg on timolol 0.5%; this difference was not statistically significant (p = 0.19). The difference between the two study groups in the change of IOP from baseline was 0.62 mmHg; the 90% CI of -0.09 to +1.33 mmHg was within the pre-specified limits of -1.5 to +1.5 mmHg, demonstrating equivalence between timolol 0.1% gel and timolol 0.5%. The plasma levels of timolol (ng/ml) at 12 weeks in the timolol 0.1% gel group were significantly less than that with timolol 0.5%, both before instillation (mean 0.057, SD 0.131 and mean 0.470, SD 0.519, respectively, p = 0.025) and after instillation (mean 0.552, SD 0.992 and mean 2.473, SD 1.780, respectively, p = 0.008). Both treatments were well tolerated with no statistically significant difference between the groups in the occurrence of ocular or systemic adverse events.
P. Sunder Raj, FRCS, Novartis Ophthalmics, Delta House, Southwood Crescent, Farnborough, Hampshire, GU14 0NL, UK. palaniswamy.sunderraj@pharma.novartis.com
Classification:
11.3.4 Betablocker (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
