Status:
COMPLETED
Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop
Lead Sponsor:
Cloudbreak Therapeutics, LLC
Collaborating Sponsors:
Novotech (Australia) Pty Limited
Conditions:
Myopia, Progressive
Eligibility:
All Genders
18-36 years
Phase:
PHASE1
PHASE2
Brief 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 do...
Detailed 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. S...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05372991
Start Date
July 20 2022
End Date
January 20 2023
Last Update
January 27 2023
Active Locations (1)
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1
USC
Brisbane, Australia