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NCT05372991 | Completed | Myopia, Progressive

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

Cloudbreak Therapeutics, LLC

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.

Condition or disease

Myopia, Progressive

Intervention/treatment

CBT-009

Vehicle

Atropine Sulfate

Phase

Phase 1

Phase 2

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 Type : Interventional
Estimated Enrollment : 84 participants
Masking : Double
Primary Purpose : Treatment
Official Title : A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers
Actual Study Start Date : July 20, 2022
Estimated Primary Completion Date : January 18, 2023
Estimated Study Completion Date : January 20, 2023
Arm Intervention/treatment

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.

Drug: Atropine Sulfate

Placebo Comparator: vehicle

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

Drug: Vehicle

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.

Drug: CBT-009

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.

Drug: CBT-009

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.

Drug: CBT-009
Ages Eligible for Study: 18 Years to 36 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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
Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Australia,

USC

Brisbane, Australia,