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Abstract #21994 Published in IGR 10-4
24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma
Feldman RM; Stewart RH; Stewart WC; Jia G; Smugar SS; Galet VACurrent Medical Research and Opinion 2008; 24: 2403-2412
OBJECTIVE: To evaluate the 24-hour efficacy and tolerability of 2% dorzolamide/0.5% timolol fixed combination (DTFC) solution in open-angle glaucoma and ocular hypertension. Research design and methods: Randomized, parallel, double-masked, multicenter study. Patients with insufficiently controlled intraocular pressure (IOP ≥ 22 mmHg) were randomized to DTFC (N = 117) or timolol (N = 115). IOP was measured at baseline, 6 weeks, and 8 weeks, with measurements taken at 6 p.m., 8 p.m., 10 p.m., 2 a.m., 6 a.m., 8 a.m., 10 a.m., and 2 p.m. (ClinicalTrials.gov identifier: NCT00108017). MAIN OUTCOME MEASURES: Statistically significant change in IOP from untreated baseline for DTFC at all hours at week 8. Secondary outcome measures included: IOP-lowering at week 6 at all individual time points, change from baseline to 8 weeks in mean daytime IOP (average of 8 a.m., 10 a.m., 2 p.m., 6 p.m., and 8 p.m. IOPs) and night-time IOP (10 p.m., 2 a.m., 6 a.m.), and comparison of DTFC with timolol after 8 weeks. RESULTS: Patients receiving DTFC had a statistically significant and clinically relevant reduction in IOP at week 8 compared with baseline at all eight time points (p < 0.001). Significant IOP reductions were also seen at all time points at week 6 (p < 0.001). DTFC significantly lowered mean daytime IOP and night-time IOP (p < 0.001 for both). Timolol alone also significantly reduced IOP from baseline at 8 weeks for all diurnal time points, and mean daytime and night-time IOP (p < 0.001 for all). Compared with timolol alone, there were significantly greater reductions with DTFC at 10 a.m. (p = 0.003) and 2 p.m. (p = 0.016), and for mean daytime IOP (p = 0.025) at 8 weeks. Significant between-treatment differences were not observed at other time points. Both treatments were well-tolerated, with no differences observed in the safety profiles between the treatment groups. CONCLUSIONS: Both DTFC and timolol provided significant IOP reduction over the entire 24-hour measurement period. Although this study was not designed or powered to compare DTFC and timolol, DTFC exhibited greater IOP-lowering than timolol during the daytime, but not at night.
Dr. R.M. Feldman. The University of Texas Health Science Center at Houston, Department of Ophthalmology, Cizik Eye Clinic, 6400 Fannin Street, Houston, TX 77030, USA. rmfeldman@swbell.net
