Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CBT-001 single dose · 1 trial · 1 indication
The primary efficacy variable is the change from baseline (Day 1) in severity grade of pterygium vascularity at Week 4. Pterygium vascularity intensity is based on color coordinates as measured by digital image analysis of pterygium photographs. The quantitative analysis of photographs using a 5-point Pterygium Hyperemia Grading Scale (0 = absent, 1 = trace, 2 = mild, 3 = moderate, 4 = severe) will be conducted at an independent image reading center.
The ocular safety and tolerability are measured by biomicroscopy, ophthalmoscopy, intraocular pressure and visual acuity, and to assess general safety by physical exams, vital signs, clinical laboratory tests and adverse events reporting
| Arm | Type | Description |
|---|---|---|
| CBT-001 Ophthalmic Solution Single dose | EXPERIMENTAL | One drop in the study administered one time only for one day |
| Vehicle | PLACEBO_COMPARATOR | One drop in the study administered three times daily (TID) for 4 weeks |
| CBT-001 Ophthalmic Solution Multidose | EXPERIMENTAL | One drop in the study administered three times daily (TID) for 4 weeks |
| Name | Type | Description |
|---|---|---|
| CBT-001 single dose | DRUG | One drop in the study administered one time |
| Vehicle | DRUG | One drop in the study administered three times daily (TID) for 4 weeks |
| CBT-001 Multi-dose | DRUG | One drop in the study administered three times daily (TID) for 4 weeks |
Inclusion Criteria: * Primary pterygium with moderate vascularity (Pterygium Hyperemia Grading Scale ≥ 3) Exclusion Criteria: * Active ocular disease, corneal abnormalities other than pterygium, active ocular infection, or any ocular pathology unrelated to pterygium in either eye that could affec...
CBT-001 single dose is an investigational small molecule being developed for the treatment of pterygium, a growth of tissue on the eye's surface. It is formulated as an ophthalmic solution and is currently in clinical development for this condition.
CBT-001 single dose is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical research on this ophthalmic solution for pterygium.
CBT-001 single dose is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 2 trial has been completed to evaluate its safety and efficacy in patients with pterygium.
CBT-001 single dose has one completed Phase 2 clinical trial, identified as NCT03049852, titled 'Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium.' This randomized, double-blind, placebo-controlled trial enrolled 75 participants in the United States.
CBT-001 single dose refers to a single-dose administration of CBT-001, an ophthalmic solution. The clinical trial NCT03049852 evaluated CBT-001 ophthalmic solution in patients with pterygium, and the single-dose formulation is part of this development program.