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

NCT05372991 | Completed Phase 1 DMC

• 1 other identifier: CBT-CS201
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (3)

• 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

• Safety on accommodation

  The accommodation will be measured using a near point rule with best-corrected distance spectacle correction at Day 28.

  28 days

• Safety on mesopic and photopic pupil

  Mesopic pupil size and photopic pupil size will be measured with a pupillometer at Day 28.

  28 days

Study Arms (5)

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.

Drug: Atropine Sulfate

vehicle

PLACEBO COMPARATOR

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

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.

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.

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.

Drug: CBT-009

Interventions

CBT-009 DRUG

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

Also known as: Atropine

CBT-009, High Dose; CBT-009, Low Dose; CBT-009, Mid Dose

Vehicle DRUG

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

Also known as: Without Atropine

vehicle

Atropine Sulfate DRUG

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

Also known as: 0.025% eyedrop aqueous solution

0.025% atropine sulphate

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer without any active ocular diseases
• years of age
• Able to provide written informed consent and comply with study assessments for the full duration of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Cloudbreak Therapeutics, LLC: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

USC

Brisbane, Australia

Location

MeSH Terms

Conditions

Myopia, Degenerative

Interventions

Atropine

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Tanya Revell, MD

  University of Sunshine Coast，Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 13, 2022
• Study Start: July 20, 2022
• Primary Completion: January 18, 2023
• Study Completion: January 20, 2023
• Last Updated: January 27, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)