Fraser

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 safety and effectiveness of AGN-193408 SR in people with open-angle glaucoma or ocular hypertension. This Phase 1/2 study includes different study designs such as an initial open-label dose escalation and later randomized, masked, parallel groups to compare treatments. The study focuses on participants with these eye conditions and aims to measure changes in intraocular pressure and monitor any treatment-related side effects over 36 months. The study uses an implant called AGN-193408 SR, which contains a preservative-free drug dispersed in a biodegradable polymer. The implant is inserted into the front chamber of the study eye using a preloaded applicator. Comparator treatments include topical eye drops of Lumigan 0.01% in the fellow eye and sham administrations using a needleless applicator that simulates the implant procedure. Vehicle eye drops are used for masking in certain cohorts. Treatment schedules vary by cohort, with daily evening eye drops starting from Day 1 in some groups. Participants will be involved in regular assessments to track intraocular pressure changes and any adverse events from baseline up to 36 months. Evaluations include eye exams, monitoring for side effects, and adherence to treatment protocols. Researchers will measure the main outcomes by comparing intraocular pressure at hour 0 from baseline to 36 months and counting participants who experience treatment emergent adverse events during this time frame. The study includes safety follow-up and long-term monitoring throughout the 3-year period.

This research aims to evaluate the rate of malposition and related clinical problems of the Hydrus Microstent device within 24 months after surgery in patients with primary open angle glaucoma. Participants will have an operable, age-related cataract and a diagnosis of glaucoma treated with up to four eye pressure-lowering medications. The study is a prospective, non-randomized, single-arm clinical trial sponsored by Alcon following acquisition of Ivantis, Inc. Participants will undergo uncomplicated cataract surgery using standard anesthesia and phacoemulsification, followed by implantation of a commercially available monofocal intraocular lens (IOL) and placement of the Hydrus Microstent device through the trabecular meshwork into Schlemm's canal. The Hydrus Microstent is a crescent-shaped nitinol device designed as a permanent implant to help fluid drainage in the eye. The study involves a screening visit, surgery on Day 0, and eight follow-up visits scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. Researchers will monitor the occurrence of clinically significant device malposition and any related clinical effects during this 24-month postoperative period. Assessments will include visual acuity, intraocular pressure, optic nerve appearance, and other protocol-defined evaluations to ensure safety and device performance.