Myopia, ProgressivePhase 1/2NCT05372991
Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop
A Phase 1/2 study testing CBT-009 and Atropine Sulfate in people with Myopia, Progressive, run by Cloudbreak Therapeutics, LLC at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- CBT-009 and Atropine Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Jul 2022to 20 Jan 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers
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.
Read the 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.
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.
- Conditions
- Myopia, Progressive
- Being tested
- CBT-009, Vehicle, Atropine Sulfate
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-009Drug
Also called Atropine
This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.
VehicleDrug
Also called Without Atropine
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 SulfateDrug
Also called 0.025% eyedrop aqueous solution
This is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| 0.025% atropine sulphate | Active comparator | 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. Receives: Drug: Atropine Sulfate |
| vehicle | Placebo comparator | CBT-009 vehicle formulation is a proprietary sterile ophthalmic solution that does not contain CBT-009 drug substance. Receives: Drug: Vehicle |
| CBT-009, Low Dose | Experimental | CBT-009 low dose formulation is a proprietary sterile ophthalmic solution that contain low dose of CBT-009 drug substance. Receives: Drug: CBT-009 |
| CBT-009, Mid Dose | Experimental | CBT-009 mid dose formulation is a proprietary sterile ophthalmic solution that contain mid dose of CBT-009 drug substance. Receives: Drug: CBT-009 |
| CBT-009, High Dose | Experimental | CBT-009 high dose formulation is a proprietary sterile ophthalmic solution that contain high dose of CBT-009 drug substance. Receives: Drug: CBT-009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Safety on accommodation
The accommodation will be measured using a near point rule with best-corrected distance spectacle correction at Day 28.
Measured: 28 days
Safety on mesopic and photopic pupil
Mesopic pupil size and photopic pupil size will be measured with a pupillometer at Day 28.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start20 Jul 2022
- Primary completion18 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cloudbreak Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Tanya Revell, MD, Principal investigator, University of Sunshine Coast，Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372991
- Sponsor's protocol ID
- CBT-CS201
- Status last verified
- May 2022
- First submitted
- 5 May 2021
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05372991
- Acronym / sponsor ID
- CBT-CS201
- Conditions
- Myopia, Progressive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cloudbreak Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.025% atropine sulphate | Active comparator | Drug: Atropine SulfateThe comparator formulation of 0.025% atropine sulfate monohydrate in normal saline will be prepared by diluting commercial 1% atropine sulphate solution with physiologic saline. |
| vehicle | Placebo comparator | Drug: VehicleCBT-009 vehicle formulation is a proprietary sterile ophthalmic solution that does not contain CBT-009 drug substance. |
| CBT-009, Low Dose | Experimental | Drug: CBT-009CBT-009 low dose formulation is a proprietary sterile ophthalmic solution that contain low dose of CBT-009 drug substance. |
| CBT-009, Mid Dose | Experimental | Drug: CBT-009CBT-009 mid dose formulation is a proprietary sterile ophthalmic solution that contain mid dose of CBT-009 drug substance. |
| CBT-009, High Dose | Experimental | Drug: CBT-009CBT-009 high dose formulation is a proprietary sterile ophthalmic solution that contain high dose of CBT-009 drug substance. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-009Also: AtropineThis is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers. | Drug | CBT-009, High Dose, CBT-009, Low Dose, CBT-009, Mid Dose |
| VehicleAlso: Without AtropineThis is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers. | Drug | vehicle |
| Atropine SulfateAlso: 0.025% eyedrop aqueous solutionThis is a Two-Stage Phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of CBT-009 eye drop in healthy volunteers. | Drug | 0.025% atropine sulphate |
Primary outcome
Safety on near visual acuity
Time frame: 28 days
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.
Safety on accommodation
Time frame: 28 days
The accommodation will be measured using a near point rule with best-corrected distance spectacle correction at Day 28.
Safety on mesopic and photopic pupil
Time frame: 28 days
Mesopic pupil size and photopic pupil size will be measured with a pupillometer at Day 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Myopia, Progressive
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
RecruitingPhase 2
Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia
Myopia Progressing
Active, not recruitingPhase 3
MAD Trial: Myopia Atropine Dose
Progressive Myopia
Active, not recruiting
Myopia Control With a Innovative Spectacle Lens - A Cessation Study
Myopia Progressing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Revell, MD principal investigator
University of Sunshine Coast，Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CBT-009 and Atropine Sulfate in people with Myopia, Progressive, run by Cloudbreak Therapeutics, LLC at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety on near visual acuity (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.