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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372991
• Other study ID #: CBT-CS201
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Myopia, Degenerative
• Myopia, Progressive

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