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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05372991




Registration number
NCT05372991
Ethics application status
Date submitted
5/05/2021
Date registered
13/05/2022
Date last updated
27/01/2023

Titles & IDs
Public title
Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop
Scientific title
A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers
Secondary ID [1] 0 0
CBT-CS201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia, Progressive 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CBT-009
Treatment: Drugs - Vehicle
Treatment: Drugs - Atropine Sulfate

Active Comparator: 0.025% atropine sulphate - The comparator formulation of 0.025% atropine sulfate monohydrate in normal saline will be prepared by diluting commercial 1% atropine sulphate solution with physiologic saline.

Placebo Comparator: vehicle - CBT-009 vehicle formulation is a proprietary sterile ophthalmic solution that does not contain CBT-009 drug substance.

Experimental: CBT-009, Low Dose - CBT-009 low dose formulation is a proprietary sterile ophthalmic solution that contain low dose of CBT-009 drug substance.

Experimental: CBT-009, Mid Dose - CBT-009 mid dose formulation is a proprietary sterile ophthalmic solution that contain mid dose of CBT-009 drug substance.

Experimental: CBT-009, High Dose - CBT-009 high dose formulation is a proprietary sterile ophthalmic solution that contain high dose of CBT-009 drug substance.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety on near visual acuity
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Safety on accommodation
Timepoint [2] 0 0
28 days
Primary outcome [3] 0 0
Safety on mesopic and photopic pupil
Timepoint [3] 0 0
28 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
36 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/01/2023
Sample size
Target
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
USC - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cloudbreak Therapeutics, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05372991
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tanya Revell, MD
Address 0 0
University of Sunshine Coast,Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries