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

Cloudbreak Therapeutics, LLC84 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia, Progressive

Interventions

CBT-009DRUG

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

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 36 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

USC

Brisbane, Australia

Outcomes

Primary Outcomes

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.

Time frame: 28 days

Safety on accommodation

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

Time frame: 28 days

Safety on mesopic and photopic pupil

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

Time frame: 28 days

Data from ClinicalTrials.gov

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