Alexandria

Researchers are studying KB801, a specially designed herpes simplex virus type 1 (HSV-1)-based vector that delivers functional human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK). This Phase 1/2, multicenter, double-masked, placebo-controlled trial aims to assess the safety, tolerability, and preliminary effectiveness of KB801 compared to a placebo in healing the persistent corneal epithelial defect (PCED) caused by NK. Participants will be randomly assigned to receive either KB801 or a placebo eye drop once daily for 8 weeks. After the treatment period, they will return for a follow-up visit 2 weeks later to check on safety and corneal healing. Additional safety follow-up visits will take place every 3 months for approximately one year to monitor the durability of the treatment effects and ongoing safety. During the study, participants will undergo evaluations to monitor adverse events and the healing of the corneal defect. The main outcomes measured are the safety and tolerability of KB801 based on the frequency and severity of side effects, as well as the rate of complete healing of the corneal defect after 8 weeks of treatment. Long-term safety will be assessed through regular follow-up visits over about one year, ensuring comprehensive monitoring throughout the study.

This research investigates dry eye disease by evaluating the safety and effectiveness of a fixed-dose combination of lifitegrast and perfluorohexyloctane given twice daily. The study is a 4-week, randomized, double-masked, parallel-group, active-controlled, multicenter trial focusing on improving signs and symptoms of dry eye disease. Participants must have a history of dry eye disease in both eyes for at least six months and meet specific symptom and sign criteria at screening and baseline. Participants will be assigned to one of several groups receiving topical eye drops for four weeks: the fixed-dose combination of lifitegrast and perfluorohexyloctane, lifitegrast alone, perfluorohexyloctane alone, or a vehicle drop without active ingredients. Each treatment is administered as an eye drop twice daily. The study compares these treatments to assess their impact on dry eye disease. Throughout the study, participants will undergo assessments including corneal fluorescein staining to measure changes from baseline at day 29. They will be monitored for adherence and safety, with evaluations of visual acuity and ocular health. The total participation time is approximately four weeks, during which researchers will track changes in dry eye disease signs and symptoms to evaluate treatment effects.

Researchers are evaluating the efficacy and safety of MELT-300, a sublingual tablet containing midazolam and ketamine, for procedural sedation in adults undergoing cataract extraction with lens replacement (CELR). This Phase 3, randomized, double-masked, placebo-controlled study includes an active comparator, sublingual midazolam, to assess the contribution of ketamine in MELT-300. The study aims to compare MELT-300 with placebo and midazolam to understand sedation effectiveness, time to sedation, and safety concerns during cataract surgery. Participants will be randomly assigned to one of three groups: MELT-300, midazolam alone, or placebo. Each participant will receive one sublingual tablet 30 (±5) minutes before surgery, without food or water, just prior to the administration of topical ocular anesthetic gel. The study involves a single day of treatment and surgery, with sedation evaluated before, during, and at the end of the surgery. Participants will be admitted on Day 1 for surgery and medication administration. Researchers will monitor sedation success, need for rescue medications, and surgery completion. Safety assessments, including monitoring adverse events, vital signs, and physical exams, will occur at baseline, during surgery, postoperatively on Day 1, and on Day 3 (±1 day). Approximately 528 adults aged 18 to 65 will participate, with follow-up to assess both efficacy and safety outcomes.

Researchers are evaluating patient and surgeon satisfaction, bruising, eyelid symmetry, wound closure success, and case time in adults undergoing blepharoplasty with the Ziplyft17 device. Ziplyft17 is a novel surgical tool designed to remove excess eyelid skin and is classified as a Class 1, 510(k) Exempt device. The study focuses on measuring outcomes related to facial appearance, eye area, and surgical efficiency over a 3-month period. Participants will undergo the blepharoplasty procedure using Ziplyft17. The study tracks the success of tissue adhesive used for wound closure and monitors postoperative bruising and eyelid symmetry. Both patient satisfaction with facial appearance and surgeon satisfaction and efficiency will be assessed from the time of enrollment until the last visit, which occurs 3 months after the procedure. During the study, participants will be evaluated at enrollment and followed up until 3 months post-procedure. Assessments include patient-reported satisfaction, surgeon feedback, measurements of eyelid symmetry, bruising, and the effectiveness of wound closure. The study also measures improvements in "eye age" and case time to evaluate the overall surgical experience and outcomes.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.