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Abstract #8347 Published in IGR 4-3
The safety and efficacy of timolol 0.5% in xanthan gum versus timolol gel forming solution 0.5%
Stewart WC; Sharpe ED; Stewart JA; Hott CECurrent Eye Research 2002; 24: 387-391
PURPOSE: To evaluate the efficacy and safety of timolol maleate 0.5% gel forming solution (TXE, Merck) versus timolol maleate 0.5% gel forming solution (TXG, Falcon) in primary open-angle glaucoma and ocular hypertension patients. METHODS: Following a washout period patients were randomly begun on either TXE or TXG each given once each morning for six weeks (Period 1). Patients then were crossed over to the opposite medicine for Period 2. Following each six-week treatment period the intraocular pressure (IOP) was obtained at 08:00 trough and +2 and +8 hours post-dosing. Anterior segment staining and photography were performed to assess surface irritation. RESULTS: Thirty-two patients were enrolled in this study; 28 completed. The diurnal IOP as well as the 08:00 trough and +2 hour post dosing pressures were statistically equal between groups, although a trend to a lower mean pressure was observed in the TXE (17.9 ± 3.2 mmHg) compared to the TXG (18.6 ± 3.4 mmHg) group. However, eight hours after dosing IOP was 17.5 ± 3.2 mmHg in the TXE group and 18.9 ± 3.3 mmHg in the TXG group (p = 0.0019). Safety was similar between groups, including corneal and conjunctival staining, conjunctival hyperemia graded by anterior segment photography and at the slit lamp, and unsolicited and solicited side effects. Vision recovery after instillation was similar between groups. CONCLUSIONS: TXE demonstrates a lower IOP eight hours after dosing than TXG does, but safety appears similar between the products.
W.C. Stewart, MD, Pharmaceutical Research Corporation, Charleston, SC 29412, USA. pr_admn@bellsouth.net
Classification:
11.3.4 Betablocker (Part of: 11 Medical treatment > 11.3 Adrenergic drugs)
