Morrow

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 bioequivalence of two eye drop treatments for adults with chronic open-angle glaucoma or ocular hypertension in both eyes. This randomized, double-blind, parallel-group clinical trial aims to compare a generic bimatoprost ophthalmic solution 0.01% with the branded LUMIGAN4 bimatoprost ophthalmic solution 0.01%. The study focuses on measuring changes in intraocular pressure IOP at specific times after dosing and monitoring safety through adverse event reports. Participants will be randomly assigned to receive either the test product or the reference product, each administered as one drop in both eyes every night at 1000 pm plus or minus one hour for 42 days 6 weeks. Before starting treatment, subjects will undergo a washout period of 4 days to 4 weeks depending on their prior medications. The treatment groups will have nearly equal numbers of participants based on baseline IOP and corneal thickness measurements. During the study, participants will have their IOP measured at 0000, 0400, and 0800 hours on Day 14 and Day 42 visits. Researchers will monitor safety by recording and analyzing any adverse events throughout the 6-week treatment period. The total participation includes screening, washout, treatment administration, and safety monitoring to assess the similarity and tolerability of the two bimatoprost eye drops.

Researchers are evaluating the safety and effectiveness of DFL24498 eye drops compared with a placebo solution in adults with Atopic Keratoconjunctivitis AKC, a condition involving inflammation and itching of the eyes. This phase 3, multicenter, randomized, double-masked study will include approximately 138 participants who meet specific criteria. The trial is sponsored by Domp Farmaceutici S.p.A and aims to provide detailed information about this treatment for AKC. The study has three main periods a screening period lasting up to one week before treatment, a 12-week treatment period where participants receive either DFL24498 or vehicle eye drops in both eyes, and a follow-up period lasting from week 13 to week 16. Rescue medication with dexamethasone sodium phosphate ophthalmic solution may be given if needed. The trial uses a randomized and triple-masked design to compare the study drug against a placebo. Participants will undergo various assessments including ocular itching scores, corneal staining, conjunctival redness, and other eye condition signs at multiple points during the study. Quality of life and patient-reported changes will also be measured. Safety will be monitored through adverse event reporting and visual acuity tests. The total participation duration spans from screening through the follow-up period, about 16 weeks in all.

Researchers are evaluating the efficacy and safety of DFL24498, a topical ophthalmic solution, compared with a vehicle solution in adults with dry eye disease. This Phase 2, randomized, double-masked, vehicle-controlled study will enroll about 417 participants aged 18 years or older across multiple centers in the US. The study duration is up to 16 weeks and consists of three distinct periods. Participants are assigned to receive either DFL24498 or the vehicle solution, both administered as one drop in each eye four times daily for 12 weeks. The study includes a vehicle-controlled parallel group design. After the 12-week treatment period, there is a 2-week follow-up phase to monitor safety and outcomes. Throughout the study, participants will undergo assessments including corneal fluorescein staining, ocular dryness symptom evaluation using the SANDE questionnaire, tear production measurement with the Schirmer I test, and conjunctival fluorescein staining. Researchers will also track treatment-emergent adverse events. The primary outcome focuses on the change in corneal staining from baseline to week 12, with safety monitored during and after treatment.

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.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.