West Fargo

Researchers are evaluating KB801, a special virus-based treatment designed to deliver human nerve growth factor to the corneas of people with Stage 2 or 3 neurotrophic keratitis, a condition that affects corneal healing. This Phase 12 study is designed to assess the safety, tolerability, and early signs of effectiveness of KB801 compared to a placebo. The study is double-masked and placebo-controlled, involving participants with persistent corneal epithelial defects that have not improved. Participants will be randomly assigned to receive either KB801 or a placebo, applied topically to the affected eye once daily for 8 weeks. After completing treatment, they will return for a follow-up visit two weeks later to check on safety and the stability of corneal healing. Further safety monitoring will take place every three months for about one year while participants remain in the study. Throughout the trial, participants will undergo regular assessments to monitor safety, including tracking any adverse events. Researchers will evaluate healing of the corneal defects using specific measurements over 8 to 10 weeks. Safety follow-up visits extend through approximately one year to observe the durability of treatment effects and overall tolerability. Participants can expect regular visits for examinations and safety monitoring during this time.

Researchers are evaluating the effects of MELT-300 on procedural sedation in adults undergoing cataract extraction with lens replacement CELR. This Phase 3 clinical trial aims to compare MELT-300 with a placebo and an active comparator, sublingual midazolam, to assess the contribution of ketamine in the combined drug product. The study focuses on the effectiveness and safety of MELT-300 during and after cataract surgery. Participants will be randomly assigned to one of three groups MELT-300 a sublingual tablet containing 3 mg midazolam and 50 mg ketamine, midazolam alone 3 mg sublingual tablet, or a placebo tablet. They will receive a single dose of the assigned medication approximately 30 minutes before surgery without food or water. The surgery will be performed under topical anesthesia, and the study medication effects will be assessed before, during, and after the procedure. Participants will be admitted on the day of surgery and monitored throughout. Researchers will assess sedation levels, the need for additional sedation or pain medication, and the ability to complete surgery. Safety will be tracked through adverse event monitoring, vital signs, and physical exams at baseline, during surgery, and up to three days after medication. The primary outcome measured is the percentage of participants achieving successful procedural sedation at various time points on the day of surgery.