Roswell

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 insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderate to severe Crohn's disease who have experienced inadequate response, loss of response or intolerance to either one prior interleukin \[IL\] antagonist, and no other biologic/small molecule (Group A); one IL antagonist and either one Janus kinase inhibitor (JAKi) or one TNFi (other than adalimumab) \[Group B\] (Cohort 1) or one prior tumor necrosis factor inhibitor \[TNFi\] and no other biologic/small molecule (Group C); one TNFi and either 1 JAKi or one IL antagonist (other than UST) (Group D) (Cohort 2). The study will look at the efficacy and safety of dual targeted therapy. The study will enroll approximately 100 participants. Participants will be assigned to one of the two treatment groups in Part A: * Part A, Cohort 1: Vedolizumab + Adalimumab * Part A, Cohort 2: Vedolizumab + Ustekinumab All participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy from Week 30 until Week 46 in Part B. Participants will be followed for a further 20-week safety follow-up period to Week 72 (or 26 weeks post-last dose of study drug). This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 76 weeks.

Researchers are evaluating the effects of combining vedolizumab intravenous infusions with oral tofacitinib tablets in adults who have moderate to severe ulcerative colitis (UC) and have not responded well to or tolerated up to two previous tumor necrosis factor (TNF) antagonist treatments. This Phase 4, open-label study focuses on the clinical remission achieved with this dual targeted therapy. The study includes about 65 participants and is being conducted at multiple centers in the United States and Canada. All participants will receive vedolizumab 300 mg intravenously together with tofacitinib 10 mg orally for the first 8 weeks. Those who respond to this combined treatment at Week 8 will then continue with vedolizumab alone for an additional 44 weeks. The total study duration for each participant can be up to 76 weeks, including a follow-up period of 26 weeks after the last dose of vedolizumab to monitor safety. During the study, participants will be regularly assessed for clinical response using the complete Mayo score at Week 8. The researchers will also monitor safety and remission status throughout the treatment and follow-up periods. Participants will undergo endoscopic evaluations, clinical exams, and laboratory tests to track their ulcerative colitis activity and response to the therapies.

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 evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study 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 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 the effectiveness of cadisegliatin as an additional treatment alongside insulin in adults with Type 1 Diabetes Mellitus. This Phase 3 trial focuses on reducing the occurrence of serious hypoglycemia (low blood sugar) events over a 26-week treatment period. The study compares cadisegliatin combined with insulin to a placebo with insulin alone to see if the new treatment lowers the risk of dangerous drops in blood sugar levels. Participants receive either cadisegliatin at a dose of 800 mg once daily, 800 mg twice daily, or a placebo, all as adjunct therapy to their insulin regimen. The study treatment lasts for 26 weeks, during which participants continue their current insulin method, either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI), without switching. Hybrid closed-loop insulin systems are not allowed. The trial is randomized, double-blind, and placebo-controlled to ensure reliable results. During the study, participants will be monitored for changes in the frequency of Level 2 or Level 3 hypoglycemia events. They must have used a continuous glucose monitoring device for at least three months before screening and maintain stable insulin therapy. Assessments include tracking hypoglycemic episodes, blood glucose levels, and HbA1c values. Safety evaluations and adherence to treatment will be closely observed throughout the 26-week period to understand the impact and safety of cadisegliatin as an adjunct therapy in this population.

Distal symmetric polyneuropathy, commonly known as diabetic neuropathy, is the most frequent neurological complication of diabetes and a major cause of disability. It causes gradual loss of function in the longest nerve fibers, leading to sensory loss, risk of foot ulcers, amputations, and pain primarily in the toes and feet. This condition generally cannot be reversed, so treatment focuses on slowing its progression and preventing complications. The study focuses on the most common form, distal symmetric sensorimotor polyneuropathy, affecting millions worldwide and often misdiagnosed with limited treatment options. This research evaluates the use of semiconductor embedded therapeutic socks over a 12-week rehabilitation period to manage diabetic neuropathy symptoms. Unlike compression socks, these therapeutic socks use body heat to activate elements that emit mid and far infrared waves and release negative ions. These biological effects aim to increase blood flow, reduce inflammation and pain, and improve function. The study compares these socks against placebo socks without the embedded technology to assess their impact on circulation and symptom relief. Participants will be assessed before and after treatment using patient-reported outcomes like the Lower Extremity Functional Scale, Michigan Neuropathy Screening Instrument, and Quality of Life Questionnaire for diabetic neuropathy. The study includes regular monitoring of symptoms and function over 12 weeks. Researchers will track changes in nerve function, pain, and quality of life to understand the potential benefits of the therapeutic socks for managing diabetic neuropathy.