Overview

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

Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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. Low pH of 3-6 is used to increase the stability of atropine in solution, however this can irritate the eye. ADS Pharmaceutical has developed a novel atropine formulation.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Cloudbreak Therapeutics, LLC
Collaborator:
Novotech (Australia) Pty Limited
Treatments:
Atropine
Criteria
Inclusion Criteria:

Heathy 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