South Orange Village

This research aims to evaluate and compare the effectiveness and safety of a new artificial tear formulation called ABBV-444 with Refresh Optive Unit Dose in adults diagnosed with Dry Eye Disease (DED), a chronic condition caused by insufficient or poor-quality tear production. The study is a Phase 3, multicenter, double-masked, randomized trial involving around 250 adult participants across approximately 20 sites in the United States. Participants begin the study with a 7-day run-in period using REFRESH PLUS eye drops. Those who meet eligibility criteria are then randomly assigned to receive either ABBV-444 eye drops or REFRESH OPTIVE Unit Dose eye drops. Both groups will use their assigned treatment for a 90-day period. These are topical eye drop treatments administered regularly during the study. During the study, participants will attend multiple visits at the study sites for medical assessments and to complete questionnaires. Researchers will monitor changes in symptoms using the Ocular Surface Disease Index (OSDI) score from baseline to day 90 and track any adverse events. The study includes detailed eye tests such as tear breakup time and staining assessments to evaluate treatment effects and safety over the 90-day treatment period.

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.

Researchers are evaluating the safety of the IC-8 Apthera intraocular lens (IOL) after treatment for posterior capsular opacification (PCO), a common complication following IC-8 Apthera IOL implantation. This post-approval study is prospective, multi-center, and non-randomized, focusing on subjects who have previously received the IC-8 Apthera IOL and later developed PCO requiring Nd:YAG laser capsulotomy treatment. The study aims to monitor safety outcomes following this laser treatment using a standardized technique after sufficient surgeon training. Participants will receive the Nd:YAG laser capsulotomy treatment to address PCO in the eye with the IC-8 Apthera IOL. The study involves a single group of subjects, all having undergone prior IC-8 Apthera IOL implantation, with the other eye implanted with a monofocal or monofocal toric IOL. The study includes about six visits over a 24-month period following the IC-8 Apthera IOL implantation, during which safety and treatment outcomes will be assessed. During the study, subjects will be monitored for several outcomes including rates of additional Nd:YAG laser treatments, treatment complications, intraocular lens related assessments, secondary surgical interventions, serious adverse events, ocular adverse events, and subjective visual disturbances using specific questionnaires. Safety and effectiveness assessments will be conducted across the 24 months post-implantation, ensuring comprehensive evaluation of the IC-8 Apthera IOL after PCO treatment.