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Found 2 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Healthy Volunteer
Researchers are investigating how women with dysmenorrhea, a condition causing painful periods, respond in their musculoskeletal and autonomic nervous systems to painful internal stimuli compared to women without this pain. The study also aims to see if awareness of internal body sensations influences this response. This case-control study focuses on understanding the connections between body awareness, musculoskeletal function, and pain perception in women aged 18 to 35 with regular menstrual cycles. Participants will be divided into two groups based on their menstrual pain levels: those with pain ratings of 4 or higher and controls with pain ratings of 3 or lower. The study includes an initial session for demographic information, pain assessment, and training on tracking menstrual cycles and heart rate variability (HRV) daily for 30 days using apps. On lab day, participants will undergo heart rate variability measurements, heartbeat counting tasks, and hip mobility testing. A vaginal balloon will be inserted and inflated to cause pain, while hip mobility and muscle strength are measured before and after the pain stimulus. During participation, women will wear a gown and undergo a series of tests in a temperature-controlled room. Researchers will assess changes in hip motion, muscle strength, and heart rate variability in response to the visceral pain stimulus. Data from daily HRV tracking and menstrual cycle monitoring will support the analysis. The study focuses on changes from baseline immediately after painful stimulation and throughout the testing session, lasting about 60 minutes in the lab.