Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop

Myopia, Progressive Clinical Trial

Official title: A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.

CBT-009 has the active ingredient of atropine, which at low doses, has shown to be effective in slowing down myopic deterioration. Current atropine products are prone to degradation once the container is open to the air. ADS Pharmaceutical has developed a novel atropine formulation.

Clinical Trial Description

Type of Study:

Stage 1: Single center, open-labeled, vehicle-controlled, single ascending dose.

Stage 2: Parallel, double-masked, randomized, vehicle-controlled with dosing once-daily in one eye.

Study Population:

Male or female healthy volunteers aged 18-36 years.

Number of Subjects and Sites:

Stage 1: Enrollment is planned for approximately 32 healthy volunteers with 8 subjects per cohort for a total of 4 cohorts.

Stage 2: Enrollment is planned for approximately 50 healthy volunteers with 25 subjects per cohort for a total of 2 cohorts.

Duration of Study Participation:

Stage 1: One day. Stage 2: 28 days of treatment with no follow-up observations. ;

Related Conditions & MeSH terms

• Myopia, Degenerative
• Myopia, Progressive

• NCT number: NCT05372991
• Study type: Interventional
• Source: Cloudbreak Therapeutics, LLC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 20, 2022
• Completion date: January 20, 2023