Petaluma

Researchers are evaluating the safety and effectiveness of licaminlimab eye drops compared to a placebo vehicle in adults with Dry Eye Disease DED who have a specific TNFR1 genotype. This study is a phase 2b3, double-masked, randomized, vehicle-controlled trial aimed at understanding how licaminlimab affects symptoms of dry eye in this particular group. Participants first undergo a run-in period using artificial tear drops three times daily for about 14 days. Following this, they are randomly assigned to receive either licaminlimab eye drops or a placebo vehicle, both administered three times daily for 29 days. The study compares these two treatments to assess their impact on dry eye discomfort. During the study, participants eye discomfort severity is measured at the start and after 29 days of treatment, focusing especially on those with the specific genotype. Additional assessments include overall symptom changes regardless of genotype. The study tracks safety and effectiveness over this period, with the total participation lasting approximately 43 days including the run-in and treatment phases.

Researchers are evaluating a preservative-free version of Bimatoprost ophthalmic solution 0.01% YSBP compared to Lumigan4 bimatoprost ophthalmic solution 0.01% in adults with primary open-angle glaucoma POAG or ocular hypertension OH. The study aims to determine if the preservative-free formulation is not worse than the existing treatment in controlling these eye conditions. This is a Phase 3 clinical trial sponsored by YS Life Science Co., Ltd., focused on treatment effectiveness and safety. Participants are randomly assigned to receive either the preservative-free Bimatoprost YSBP or Lumigan4 eye drops. The treatments are administered as eye drops, and the study uses a parallel design with two groups treated simultaneously. The trial is double-masked, meaning neither participants nor investigators know which treatment is given. The primary treatment period lasts 12 weeks, during which intraocular pressure IOP is closely monitored. During the study, participants undergo regular assessments including IOP measurements at baseline and Week 12. Visual acuity is also evaluated to ensure participants meet vision criteria. The study monitors adherence to the treatment and any side effects. The main outcome measured is the change in intraocular pressure at Week 12 to assess the treatments effect on eye pressure control. The total study duration extends through the treatment period and concludes by December 2027.

Glaucoma is a leading cause of blindness worldwide, second only to cataracts. This research evaluates the safety and effectiveness of the XEN63 gel stent implanted using two different surgical methods ab interno inside the eye and ab externo outside the eye. The study focuses on patients with glaucoma that is not controlled by medication or previous surgery, assessing adverse events and intraocular pressure over time. Participants will be assigned to one of two groups. One group will receive the XEN63 gel stent implanted via the ab interno approach, while the other group will have it implanted via the ab externo approach. The implantation happens on Day 1, and participants will be followed for 12 months to monitor outcomes. During the study, participants will attend regular visits at hospitals or clinics to assess safety and the stents effect on glaucoma. Medical assessments and eye examinations will be conducted to measure intraocular pressure and monitor adverse events. The primary outcomes include the proportion of participants achieving a significant reduction in intraocular pressure and the number experiencing adverse events over the 12-month period.

Researchers are evaluating the safety and effectiveness of NEXAGON4 lufepirsen ophthalmic gel in people with persistent corneal epithelial defects PCED, a condition where the corneal surface does not heal properly. This randomized, double-masked, vehicle-controlled study aims to understand how well NEXAGON works in treating PCED and its durability after treatment. This Phase 2 trial is sponsored by Glaukos Corporation and is conducted at multiple centers. Participants will be randomly assigned to receive one of three treatments applied topically to the eye once a week for 4 to 8 weeks a high dose of lufepirsen, a low dose of lufepirsen available only at EU sites, or a vehicle gel without the active drug. After the treatment period, a 4-week follow-up will monitor the condition. If the corneal defect does not heal or the healing is not maintained for 28 days, participants may enter an open-label treatment phase with NEXAGON for an additional 8 weeks. During the study, participants will undergo screening to confirm eligibility, receive weekly treatment applications, and be monitored for safety and healing progress. Researchers will assess corneal re-epithelialization and its durability as the main outcome. The total study participation includes the screening, up to 8 weeks of treatment, 4 weeks of follow-up, and possibly an 8-week open-label extension. Safety, efficacy, and healing durability will be closely observed throughout these periods.

Researchers are evaluating the bioequivalence of two eye drop treatments, Bimatoprost 0.01% ophthalmic solution by Amneal EU and LUMIGAN4 bimatoprost ophthalmic solution 0.01% by Allergan, in adults with chronic open-angle glaucoma or ocular hypertension affecting both eyes. This randomized, double-blind, parallel-group study aims to compare these treatments by measuring their effects on intraocular pressure IOP as the primary clinical endpoint. Participants will be randomly assigned to receive either the test or reference bimatoprost eye drops, instilling one drop in both eyes every evening around 1000 pm for 42 days. The study includes multiple doses over this period, with evaluations occurring at baseline, two weeks, and six weeks. The test and reference products are both ophthalmic solutions containing the same concentration of bimatoprost. Throughout the study, participants will have clinical assessments to monitor safety and efficacy, including IOP measurements at specific times 0000, 0400, and 0800 hours on days 14 and 42. Safety monitoring for adverse events will continue during the six-week treatment period. The main outcome is the mean difference in IOP between the treatment groups, helping to determine if the test product is equivalent to the reference product in controlling eye pressure.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.