Roswell

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.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

This research aims to evaluate the effects of vedolizumab intravenous IV combined with either adalimumab or ustekinumab in adults with moderate to severe Crohns Disease who have not responded adequately or have lost response to certain prior treatments. The study investigates the safety and efficacy of these dual targeted therapies, followed by vedolizumab alone. Approximately 100 participants will be enrolled, with the overall study duration lasting about 76 weeks. Participants in Part A will receive dual targeted therapy one group will get vedolizumab IV plus adalimumab subcutaneous injections, and another group will receive vedolizumab IV combined with ustekinumab through initial IV infusion followed by subcutaneous doses. Those who respond to Part A treatment will continue in Part B, receiving vedolizumab IV monotherapy every 8 weeks from Week 30 to Week 46. After treatment, participants will have a safety follow-up period extending to Week 72. During the study, participants will undergo multiple assessments including endoscopic evaluations using the Simple Endoscopic Score for Crohns Disease SES-CD at Weeks 26 and 52. Clinical remission and symptom remission will be tracked at various time points using the Crohns Disease Activity Index CDAI and patient-reported outcome measures. Safety monitoring and follow-up continue for at least 26 weeks after the last treatment dose to evaluate treatment effects and adverse events throughout the study period.

Researchers are evaluating the effect of combining vedolizumab intravenous infusions with oral tofacitinib tablets in adults aged 18 to 65 with moderate to severe ulcerative colitis who have not responded adequately to certain prior treatments. This phase 4 study focuses on clinical remission rates and treatment response in this population, aiming to understand the benefits of dual targeted therapy followed by vedolizumab alone. All participants first receive vedolizumab 300 mg via IV infusion at Weeks 0, 2, and 6 plus tofacitinib 10 mg tablets twice daily from Week 0 to Week 8. Those who respond clinically at Week 8 continue with vedolizumab 300 mg IV every 8 weeks alone through Week 46. The study lasts up to 76 weeks including treatment and follow-up. Participants undergo clinical assessments including Mayo score evaluations at multiple timepoints to measure remission and response. Safety is monitored through adverse event tracking and laboratory tests up to 26 weeks after the last vedolizumab dose. Patient questionnaires on quality of life and fatigue are also collected, with total participation extending over a year.

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 Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

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.

Distal symmetric polyneuropathy, also called diabetic neuropathy, is a common nerve complication of diabetes that affects the longest nerve fibers, especially in the toes and feet. It causes sensory loss, pain, and increases the risk of foot ulcers and amputations, which lowers quality of life. This condition is usually not reversible, and current management focuses on slowing its progression and preventing complications. The study aims to evaluate the use of semiconductor embedded therapeutic socks in managing this condition over a 12-week rehabilitation period. The study compares the effects of semiconductor embedded therapeutic socks, which emit mid and far infrared waves and negative ions to improve blood flow and reduce inflammation, against placebo socks that do not contain this fabric. Participants will wear these socks during the 12-week treatment phase. The socks technology is believed to activate biological pathways that reduce pain and inflammation locally, unlike systemic treatments. The study will collect outcome measures at standard intervals to assess the socks impact on diabetic neuropathy symptoms and function. Participants will be assessed before and after treatment using specific questionnaires and physical exams to measure function, pain, symptom severity, and foot tissue oxygenation. Compliance with sock use will be monitored weekly. The primary outcome is improved patient function measured by standardized scales over 12 weeks. Secondary outcomes include pain reduction, symptom improvement, and better blood oxygen levels in the feet. The study is randomized, double-blind, and will last at least 12 weeks for each participant.

This research aims to evaluate the safety and performance of the Enhanced Lithotripsy System ELS for treating urinary stones in adults. The study focuses on patients aged 21 or older who have a single urinary stone in the ureter. The purpose is to assess how well the ELS can break stones into small fragments that can pass more easily, potentially reducing discomfort. Participants will receive the ELS procedure, which uses low pressure ultrasound combined with microbubbles to pit and fragment the urinary stones. All participants undergo this experimental procedure, and no placebo or comparison group is involved. The study includes follow-up evaluations at 30 days and, if necessary, at 60 days to check for remaining stone fragments via CT scans. During the study, participants will be monitored for stone presence using CT imaging and assessed for changes in pain levels, quality of life, and return to normal daily activities and work. Safety and effectiveness will be evaluated up to 30 days after treatment, with an additional assessment at 60 days if stones remain. The total study duration extends from the procedure through these follow-up periods.