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CBT-009 · 1 trial · 1 indication
Near visual acuity will be assessed using best-corrected distance spectacle correction with a reduced logMAR reading chart placed at 40 cm under well-lit conditions at Day 28.
The accommodation will be measured using a near point rule with best-corrected distance spectacle correction at Day 28.
Mesopic pupil size and photopic pupil size will be measured with a pupillometer at Day 28.
| Arm | Type | Description |
|---|---|---|
| 0.025% atropine sulphate | ACTIVE_COMPARATOR | The comparator formulation of 0.025% atropine sulfate monohydrate in normal saline will be prepared by diluting commercial 1% atropine sulphate solution with physiologic saline. |
| vehicle | PLACEBO_COMPARATOR | CBT-009 vehicle formulation is a proprietary sterile ophthalmic solution that does not contain CBT-009 drug substance. |
| CBT-009, Low Dose | EXPERIMENTAL | CBT-009 low dose formulation is a proprietary sterile ophthalmic solution that contain low dose of CBT-009 drug substance. |
| CBT-009, Mid Dose | EXPERIMENTAL | CBT-009 mid dose formulation is a proprietary sterile ophthalmic solution that contain mid dose of CBT-009 drug substance. |
| CBT-009, High Dose | EXPERIMENTAL | CBT-009 high dose formulation is a proprietary sterile ophthalmic solution that contain high dose of CBT-009 drug substance. |
| Name | Type | Description |
|---|---|---|
| CBT-009 | DRUG | This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers. |
| Vehicle | DRUG | This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers. |
| Atropine Sulfate | DRUG | This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers. |
Inclusion Criteria: Healthy volunteer without any active ocular diseases * 18-36 years of age * Able to provide written informed consent and comply with study assessments for the full duration of the study Exclusion Criteria: Uncontrolled systemic disease * Active ocular disease * Any ocular su...
CBT-009 is an investigational small molecule eye drop being developed for progressive myopia. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacodynamics in healthy volunteers. The drug is not yet approved and remains under clinical investigation.
CBT-009 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker YCBD. The company is conducting clinical trials for this investigational treatment for progressive myopia.
CBT-009 is in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the safety, tolerability, and pharmacodynamics of the eye drop. The drug is investigational and has not been approved by regulatory authorities.
CBT-009 has one completed Phase 1 clinical trial registered as NCT05372991, titled "Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop." The trial enrolled 84 participants in Australia, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.
CBT-009 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for progressive myopia. A Phase 1 trial has been completed, but the drug has not yet received regulatory approval for any use.