PURPOSE: To evaluate the ocular hypotensive efficacy of 0.05%, 0.1% and 0.25% AR-12286Ophthalmic Solutions in patients diagnosed with ocular hypertension or glaucoma. DESIGN: Parallel comparison, vehicle-controlled, double-masked, 3-week randomized clinical trial. METHODS:Subjects (n = 89) with elevated intraocular pressure (IOP) were assigned randomly to receive either 1 of 3 concentrations of AR-12286 or its vehicle. Dosing was once-daily in the morning for 7 days, then once-daily in the evening for 7 days, then twice daily for 7 days. Primary and secondary efficacy end points were mean IOP at each diurnal time point (8 am, 10 am, 12 pm, and 4 pm) and mean change in IOP from baseline, respectively. RESULTS: All 3 concentrations of AR-12286 produced statistically and clinically significant reductions in mean IOP that were dose dependent, with peak effects occurring 2 to 4 hours after dosing. Mean IOP at peak effect ranged from 17.6 to 18.7 mm Hg (-6.8 to -4.4 mm Hg) for the 3 concentrations. The largest IOP reductions were produced by 0.25% AR-12286 after twice daily dosing (up to -6.8 mm Hg; 28%). The 0.25% concentration dosed once-daily in the evening produced highly significant IOP reductions throughout the following day (-5.4 to -4.2 mm Hg). The only adverse event of note was trace (+0.5) to moderate (+2) conjunctival hyperemia that was transient, typically lasting 4 hours or less. After once-daily evening dosing, hyperemia was seen in less than 10% of patients. CONCLUSIONS:AR-12286 was well tolerated and provided clinically and statistically significant ocular hypotensive efficacy in patients with ocular hypertension and glaucoma.
RCT Entities:
PURPOSE: To evaluate the ocular hypotensive efficacy of 0.05%, 0.1% and 0.25% AR-12286 Ophthalmic Solutions in patients diagnosed with ocular hypertension or glaucoma. DESIGN: Parallel comparison, vehicle-controlled, double-masked, 3-week randomized clinical trial. METHODS: Subjects (n = 89) with elevated intraocular pressure (IOP) were assigned randomly to receive either 1 of 3 concentrations of AR-12286 or its vehicle. Dosing was once-daily in the morning for 7 days, then once-daily in the evening for 7 days, then twice daily for 7 days. Primary and secondary efficacy end points were mean IOP at each diurnal time point (8 am, 10 am, 12 pm, and 4 pm) and mean change in IOP from baseline, respectively. RESULTS: All 3 concentrations of AR-12286 produced statistically and clinically significant reductions in mean IOP that were dose dependent, with peak effects occurring 2 to 4 hours after dosing. Mean IOP at peak effect ranged from 17.6 to 18.7 mm Hg (-6.8 to -4.4 mm Hg) for the 3 concentrations. The largest IOP reductions were produced by 0.25% AR-12286 after twice daily dosing (up to -6.8 mm Hg; 28%). The 0.25% concentration dosed once-daily in the evening produced highly significant IOP reductions throughout the following day (-5.4 to -4.2 mm Hg). The only adverse event of note was trace (+0.5) to moderate (+2) conjunctival hyperemia that was transient, typically lasting 4 hours or less. After once-daily evening dosing, hyperemia was seen in less than 10% of patients. CONCLUSIONS:AR-12286 was well tolerated and provided clinically and statistically significant ocular hypotensive efficacy in patients with ocular hypertension and glaucoma.
Authors: Padmanabhan P Pattabiraman; Tommy Rinkoski; Eric Poeschla; Alan Proia; Pratap Challa; Ponugoti V Rao Journal: Am J Pathol Date: 2014-12-12 Impact factor: 4.307
Authors: Karen Y Torrejon; Ellen L Papke; Justin R Halman; Judith Stolwijk; Cula N Dautriche; Magnus Bergkvist; John Danias; Susan T Sharfstein; Yubing Xie Journal: Biotechnol Bioeng Date: 2015-12-30 Impact factor: 4.530
Authors: Uttio Roy Chowdhury; Tommy A Rinkoski; Cindy K Bahler; J Cameron Millar; Jacques A Bertrand; Bradley H Holman; Joseph M Sherwood; Darryl R Overby; Kristen L Stoltz; Peter I Dosa; Michael P Fautsch Journal: Invest Ophthalmol Vis Sci Date: 2017-11-01 Impact factor: 4.799