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

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.

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 surgical procedure within the last 3 months
• Current enrollment in an investigational drug or device study or participation in such as study within 30 days prior to entry into this study
• Any condition or situation which, in the investigator's opinion, may put the volunteer at significant risk, may confound the study results, or may interfere significantly with the volunteer's participation in the study. Allergic or sensitive to Atropine study medication or formulation excipient
• Smoking during the study
• Female patients who are pregnant, nursing, or planning a pregnancy during the study
• Current or anticipated use of topical ophthalmic medications are prohibited during the study. Volunteers must have discontinued use of ophthalmic medications for at least 2 weeks prior to Day 1 visit