Fraser

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.

This research aims to evaluate the rate of malposition and related clinical outcomes of the Hydrus Microstent within 24 months after implantation. The study focuses on adults aged 45 and older who have primary open angle glaucoma and an operable cataract. Participants will undergo cataract surgery combined with the placement of a monofocal intraocular lens IOL followed by Hydrus Microstent implantation. Participants will have the Hydrus Microstent implanted immediately after cataract surgery and IOL placement. The cataract surgery uses standard anesthesia and phacoemulsification techniques. After surgery, participants will attend follow-up visits scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24 to monitor outcomes. Throughout the study, participants will be evaluated for device positioning and any associated clinical consequences. Researchers will assess the occurrence of device malposition, intraoperative ocular adverse events, and sight-threatening or other postoperative ocular events up to 24 months after surgery. This schedule of visits and evaluations aims to gather comprehensive safety and performance data over a two-year period.