Petaluma

Glaucoma, a leading cause of blindness worldwide, is the focus of this study evaluating the safety and effectiveness of a glaucoma gel stent called XEN63. This device is intended for patients with glaucoma whose intraocular pressure (IOP) remains uncontrolled despite medical or surgical treatments. The trial compares two implantation methods: ab interno (inside the eye) and ab externo (outside the eye), enrolling about 130 participants aged 45 years or older with glaucoma. Participants receive the XEN63 gel stent implanted either by the ab interno or ab externo approach on the first day of the study. They are then monitored regularly over 12 months to assess and compare the outcomes of each implantation method. The study takes place at approximately 32 sites across the United States. Throughout the 12-month follow-up, participants attend scheduled visits at hospitals or clinics where medical assessments and eye examinations evaluate the safety and effectiveness of the gel stent. Researchers measure the percentage of participants achieving at least a 20% reduction in IOP from baseline using the same or fewer IOP-lowering medications. They also track adverse events to monitor safety during the study period.

Researchers are investigating the safety and effectiveness of NEXAGON® (lufepirsen ophthalmic gel) for people with persistent corneal epithelial defects (PCED) that do not heal with standard treatments. This randomized, multicenter, double-masked, vehicle-controlled Phase 2 study aims to see if NEXAGON can help heal these persistent eye wounds and maintain healing over time. Participants will be randomly assigned to receive either a high dose or low dose of lufepirsen gel or a matching vehicle gel without the active drug. The study includes a Screening Period, followed by a Treatment Period lasting up to 8 weeks, and a 4-week Follow-up Period. If a participant's corneal defect does not heal or if the healing is not durable for 28 days after treatment, they may enter an additional 8-week Open-label Treatment Period with NEXAGON. During the study, participants will be monitored for corneal healing and safety. Researchers will assess whether the corneal epithelium has re-formed and maintained healing for 28 days. Evaluations will include clinical exams and monitoring for any side effects. The total study participation may last up to several months depending on healing and treatment response.

Researchers are evaluating the bioequivalence of two ophthalmic solutions containing 0.01% bimatoprost in adults with chronic open-angle glaucoma or ocular hypertension affecting both eyes. This Phase 3 randomized, double-blind, parallel-group study aims to compare the effects of a test drug from Amneal EU and the reference drug LUMIGAN4 (bimatoprost ophthalmic solution) in lowering intraocular pressure (IOP), a key factor in managing these eye conditions. Participants who meet specific criteria, such as having controlled IOP after washout and similar pressure between eyes, will be randomly assigned to receive either the test or reference drug. Each subject will apply one drop in each eye every evening around 10:00 pm for 42 days. The study involves multiple clinical sites and uses a parallel design with two treatment arms to assess the drugs' bioequivalence based on their clinical effect. Throughout the study, subjects will undergo clinical evaluations to monitor safety and effectiveness. The main outcome is the mean difference in IOP between the two treatment groups, measured at multiple times (00:00, 04:00, and 08:00 hours) on Days 14 and 42. Additional assessments include visual acuity tests and ongoing safety monitoring. The total treatment period is six weeks, with key measurements taken at two and six weeks after starting treatment.

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.