Morrow

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 bioequivalence of two ophthalmic solutions for treating adults with chronic open-angle glaucoma or ocular hypertension affecting both eyes. This randomized, double-blind, parallel-group, two-arm, multiple-dose, multicenter study aims to compare a generic bimatoprost ophthalmic solution 0.01% with LUMIGAN® (bimatoprost ophthalmic solution) 0.01%. The study focuses on measuring the mean difference in intraocular pressure (IOP) between the two treatments at specified times during Weeks 2 and 6, while also monitoring safety through reported adverse events. Participants will be randomly assigned to receive one of the two bimatoprost solutions, with one drop instilled in both eyes every night at 10:00 pm (plus or minus 1 hour) for 42 days (6 weeks). Before treatment, subjects will undergo a screening period within 6 weeks and a washout period of 4 days to 4 weeks depending on their current medications. The study maintains a near 1:1 ratio of treatment distribution based on baseline IOP and central corneal thickness (CCT) to ensure balanced groups. During the study, participants will attend visits at Day 14 (Week 2) and Day 42 (Week 6) to measure IOP at three time points: 00:00 hour, 04:00 hours, and 08:00 hours. Researchers will also collect data on adverse events by assessing their nature, severity, and frequency to compare safety between the two treatments. The total participation period includes screening, washout, treatment for 6 weeks, and scheduled IOP assessments to monitor treatment effects and safety.

This research investigates dry eye disease by evaluating the safety and effectiveness of a fixed-dose combination of lifitegrast and perfluorohexyloctane given twice daily. The study is a 4-week, randomized, double-masked, parallel-group, active-controlled, multicenter trial focusing on improving signs and symptoms of dry eye disease. Participants must have a history of dry eye disease in both eyes for at least six months and meet specific symptom and sign criteria at screening and baseline. Participants will be assigned to one of several groups receiving topical eye drops for four weeks: the fixed-dose combination of lifitegrast and perfluorohexyloctane, lifitegrast alone, perfluorohexyloctane alone, or a vehicle drop without active ingredients. Each treatment is administered as an eye drop twice daily. The study compares these treatments to assess their impact on dry eye disease. Throughout the study, participants will undergo assessments including corneal fluorescein staining to measure changes from baseline at day 29. They will be monitored for adherence and safety, with evaluations of visual acuity and ocular health. The total participation time is approximately four weeks, during which researchers will track changes in dry eye disease signs and symptoms to evaluate treatment effects.

Researchers are evaluating the safety and effectiveness of DFL24498 eye drops compared to a vehicle (placebo) eye drop in adults with Atopic Keratoconjunctivitis (AKC), a chronic allergic eye condition. This phase 3 study will enroll about 138 participants aged 18 to 65 years who have AKC in both eyes and meet specific symptom and clinical criteria. The study is designed to better understand how DFL24498 affects ocular itching and other related symptoms over time. The study is divided into three parts: a screening period lasting up to 7 days before treatment starts, a 12-week treatment period where participants will receive either DFL24498 or vehicle eye drops instilled in each eye, and a follow-up period lasting from weeks 13 to 16. Rescue medication with dexamethasone sodium phosphate eye drops may be given if needed, as decided by the study doctor. Participants will be monitored throughout the study with assessments including measurement of ocular itching using a visual analog scale at baseline and week 6. Other evaluations will include eye examinations to assess corneal staining and conjunctival redness, symptom scoring, and safety monitoring. The total participation time spans from screening through the follow-up period to understand both the treatment effects and any side effects.

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 depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

Researchers are evaluating the safety, tolerability, and effectiveness of GRF312 5% ophthalmic solution in adults with Dry Eye Disease (DED) through a Phase 2, multi-site, double-blind, randomized, vehicle-controlled study. The study focuses on adults who have a history of DED and meet specific clinical criteria for moderate to severe disease. This research aims to compare GRF312 5% to a placebo vehicle to better understand its potential benefits and risks for those affected by DED. Participants will be randomly assigned to receive either the GRF312 5% eye drops or a placebo vehicle. They will self-administer these eye drops according to the study instructions throughout the treatment period. The study includes a screening phase, a run-in period, and a treatment phase lasting up to 84 days. During this time, participants will be closely monitored for any treatment-emergent adverse events, serious adverse events, and any events that may cause them to stop treatment. Throughout the study, participants will attend required visits where their visual acuity, symptom severity, and other eye health measures will be assessed. Researchers will track safety and tolerability, as well as how participants respond to the treatment. The main outcomes include the number and proportion of participants experiencing adverse events up to Day 84. Participants will need to follow the study protocol carefully and attend all scheduled visits for the duration of the trial.