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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05372991
Other study ID # CBT-CS201
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 20, 2022
Est. completion date January 20, 2023

Study information

Verified date May 2022
Source Cloudbreak Therapeutics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date January 20, 2023
Est. primary completion date January 18, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 36 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Australia USC Brisbane

Sponsors (2)

Lead Sponsor Collaborator
Cloudbreak Therapeutics, LLC Novotech (Australia) Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety on near visual acuity 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. 28 days
Primary Safety on accommodation The accommodation will be measured using a near point rule with best-corrected distance spectacle correction at Day 28. 28 days
Primary Safety on mesopic and photopic pupil Mesopic pupil size and photopic pupil size will be measured with a pupillometer at Day 28. 28 days
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