Doncaster East

Researchers are evaluating the effectiveness, safety, and tolerability of repeated doses of Cevimeline Ophthalmic Solution compared to a placebo vehicle in adults with Dry Eye Disease DED. This Phase 2, randomized, double-masked, vehicle-controlled study aims to better understand treatment options for individuals with moderate to severe DED, a condition causing eye discomfort and dryness. Participants will begin with a 14-day run-in period where they self-administer one drop of the placebo vehicle to each eye twice daily. After this, eligible subjects will be randomly assigned to one of four groups to receive either 1%, 2%, or 4% Cevimeline Ophthalmic Solution or the vehicle. They will continue self-administering the assigned treatment twice daily and attend clinic visits on Days 15, 29, 57, and 85 for evaluations. Throughout the study, participants will undergo assessments including the Schirmer test to measure tear production at various points, particularly on Day 85 as the primary outcome. Safety and tolerability will also be monitored during clinic visits. The total study period spans approximately 85 days, with detailed follow-ups to observe treatment effects and any side effects under medical supervision.

This research aims to evaluate a new delivery method of spinal cord stimulation using the Evoke System for patients with chronic pain in the trunk andor limbs. The study focuses on a novel approach called ECAP-controlled closed-loop spinal cord stimulation, which includes new software and hardware features to better manage pain. The trial is designed as a prospective, multicenter, single-arm feasibility study sponsored by Saluda Medical Pty Ltd. Participants will receive treatment with the Evoke Spinal Cord Stimulation SCS System, which continuously measures and records evoked compound action potentials ECAPs and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude. This closed-loop system aims to provide a more personalized and controlled pain management experience. The study includes only one experimental treatment group using this device. During the study, participants will be closely monitored for changes in ECAPs as measured by the Evoke SCS System through the completion of the study, which can last up to two years. Assessments will focus on the devices performance in controlling pain signals, with ongoing evaluations to track the stability and effectiveness of the stimulation. Participants will provide informed consent and comply with study requirements throughout their involvement.