Minnetonka

Researchers are evaluating KB801, a special virus-based treatment designed to deliver human nerve growth factor to the corneas of people with Stage 2 or 3 neurotrophic keratitis, a condition that affects corneal healing. This Phase 12 study is designed to assess the safety, tolerability, and early signs of effectiveness of KB801 compared to a placebo. The study is double-masked and placebo-controlled, involving participants with persistent corneal epithelial defects that have not improved. Participants will be randomly assigned to receive either KB801 or a placebo, applied topically to the affected eye once daily for 8 weeks. After completing treatment, they will return for a follow-up visit two weeks later to check on safety and the stability of corneal healing. Further safety monitoring will take place every three months for about one year while participants remain in the study. Throughout the trial, participants will undergo regular assessments to monitor safety, including tracking any adverse events. Researchers will evaluate healing of the corneal defects using specific measurements over 8 to 10 weeks. Safety follow-up visits extend through approximately one year to observe the durability of treatment effects and overall tolerability. Participants can expect regular visits for examinations and safety monitoring during this time.

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 conducting an observational study to track the natural history, clinical course, and management patterns of people with limbal stem cell deficiency LSCD. The study focuses on participants aged 12 to 99 years who have a diagnosis of LSCD. It aims to understand how this condition progresses over time by assessing changes in vision and eye structure without administering any study treatments. Participants will not receive any study drug or product as this is a non-interventional study. Instead, researchers will observe and collect information on the conditions progression and management. The study will follow participants from screening through 84 weeks, monitoring various vision-related and anatomical changes that are associated with LSCD. During the study, participants will undergo regular assessments including patient-reported outcomes and multiple vision tests such as photophobic best corrected visual acuity BCVA, low-luminance BCVA, low-contrast BCVA, and contrast sensitivity. Anatomical changes will also be evaluated through eye examinations over the 84-week period. Researchers will track both functional and structural changes to better understand LSCDs impact and progression in the study population.

Researchers are evaluating the safety and effectiveness of an investigational eye drop called CSB-001 Ophthalmic Solution 0.1% in adults with recent corneal scars caused by various eye injuries or conditions that occurred within the past 7 to 30 days. This Phase 1 study focuses on scars located near the center of the cornea that affect vision, aiming to understand how well the treatment works and how safe it is for participants. All participants will receive CSB-001 starting on Day 1, dosing either four times daily or three times daily in the affected eye for up to 14 days. If a participants scar has resolved by Day 7, they will stop treatment but continue follow-up visits. Scheduled visits occur on Days 14, 21, 28, 56, and at Month 3 to monitor progress and safety. Participants will have safety assessments including eye exams with slit-lamp biomicroscopy and vision tests from screening through Day 56. Researchers will also measure scar size, depth, volume, density, contrast sensitivity, and distance vision to evaluate the treatments effects. The study includes careful monitoring for any side effects and lasts about three months for each participant.

Researchers are evaluating the safety and effectiveness of CSB-001 Ophthalmic Solution 0.1% in adults with limbal stem cell deficiency LSCD, a condition affecting the cornea. This phase 1, open-label study involves subjects with confirmed LSCD who will receive the investigational drug in one or both eyes. The study includes multiple dosing and observation periods to assess treatment impact and safety over an extended time. Participants will receive CSB-001 eye drops four times daily during two separate 8-week dosing phases, with a 31 to 40-day break dosing holiday between them. The study is divided into phases including initial observation, dosing periods, and a non-interventional observation phase lasting up to 48 weeks. An optional extension phase allows further non-interventional observation for up to 36 months, extending total participation to about three years. Throughout the study, participants will undergo regular safety assessments including adverse event monitoring, slit-lamp biomicroscopy exams, and vision tests best-corrected distance visual acuity. Researchers will also evaluate changes in LSCD severity and vision. The study involves ongoing monitoring during dosing and observation periods, with data collected up to week 144. Participants will have several visits during these phases to assess treatment effects and safety under medical supervision.