Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
brief summary
The objectives of this study are: * To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT). * To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle. * To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.
detailed description
Placebo-controlled double-masked, multiple dose Phase 2 study in 40 patients with IOP ≥ 22 and ≤30 mmHg, evaluating ocular and systemic safety and efficacy following administration of Phentolamine mesylate 1.0% QD at 8PM to 10PM in both eyes for 14 days.
official title
Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension