A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects
The purpose of this study is to compare the safety and effectiveness of the study product, CSB001 ophthalmic solution 0.1% to placebo when treating stage 2 and 3 Neurotrophic Keratitis.
Patients diagnosed with stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer) Neurotrophic Keratitis (NK) will take part in this study.
Neurotrophic Keratitis (also called neurotrophic keratopathy) is a rare disease of the cornea that occurs when the nerves to the cornea do not function properly. In patients with neurotrophic keratitis the corneal epithelium (the outer layer of your cornea) may break down and affect vision and cause corneal ulceration.
The study product, CSB-001 ophthalmic solution 0.1%, is an investigational drug, which means it has not been approved by the United States Food and Drug Administration (FDA) for use except in research studies. CSB-001 ophthalmic solution 0.1% is an eye drop containing dHGF which is a naturally occurring hepatocyte (liver cell) growth factor. A growth factor is a substance that increases production of mature cells, such as nerve or liver cells.
The study product, CSB-001 ophthalmic solution 0.1%, will be compared to a placebo to determine its safety and efficacy when given to patients with stage 2 or 3 Neurotrophic Keratitis.
Main Procedures Involved: During the study visits you will be asked questions about your health, your vision will be checked, and the study doctor will perform several eye tests using a slit-lamp (microscope to exam the eyes), eye drops, and other routine assessments that are normal in eye clinics.
Duration of Participation: There are two phases in this study: The first phase is double-masked which means you will be assigned a treatment of either CSB-001 ophthalmic solution 0.1% or placebo and neither you nor your study doctor will know what treatment you are receiving. This phase will last 8 to 10 weeks. At Week 8, your cornea will be evaluated as to how well it has healed. If your cornea is healed at Week 8, corneal healing will be evaluated again at Week 10. If your cornea has not healed at the end of this phase, your study treatment will be revealed. If you were assigned to the placebo group, you can participate in the second phase of the study, the open-label phase. Open-label means that both you and your study doctor know you are being treated with CSB-001 ophthalmic solution 0.1%. There is no chance of being placed in the placebo treatment group again. This phase of the study will mimic the first phase of the study and will last 8 to 10 weeks. There are 9 or 10 visits in the double-masked phase of the study, depending on whether your cornea heals. There are an additional 8 or 9 visits in the open-label phase of the study, depending on whether your cornea heals. Visits are weekly for the first 8 weeks of the study. There is no visit at Week 9, however some participants will need to have a Week 10 clinic visit.
18 to 100 years
Darren Gregory, MD
Protocol Number: 21-3923
More information available at ClinicalTrials.gov: NCT04909450
Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers