Back to results

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

Primary Purpose

Myopia, Progressive

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

CBT-009

Vehicle

Atropine Sulfate

About this trial

This is an interventional treatment trial for Myopia, Progressive

Eligibility Criteria

18 Years - 36 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

0.025% atropine sulphate

vehicle

CBT-009, Low Dose

CBT-009, Mid Dose

CBT-009, High Dose

Arm Description

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.

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

CBT-009 low dose formulation is a proprietary sterile ophthalmic solution that contain low dose of CBT-009 drug substance.

CBT-009 mid dose formulation is a proprietary sterile ophthalmic solution that contain mid dose of CBT-009 drug substance.

CBT-009 high dose formulation is a proprietary sterile ophthalmic solution that contain high dose of CBT-009 drug substance.

Outcomes

Primary Outcome Measures

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.

Safety on accommodation

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05372991

First Posted

May 5, 2021

Last Updated

January 25, 2023

Sponsor

Cloudbreak Therapeutics, LLC

Collaborators

Novotech (Australia) Pty Limited

1. Study Identification

Unique Protocol Identification Number

NCT05372991

Brief Title

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

Official Title

A Two-Stage, Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of CBT-009 Eye Drop in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

July 20, 2022 (Actual)

Primary Completion Date

January 18, 2023 (Actual)

Study Completion Date

January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cloudbreak Therapeutics, LLC

Collaborators

Novotech (Australia) Pty Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia, Progressive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.025% atropine sulphate

Arm Type

Active Comparator

Arm Description

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.

Arm Title

vehicle

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

CBT-009, Low Dose

Arm Type

Experimental

Arm Description

CBT-009 low dose formulation is a proprietary sterile ophthalmic solution that contain low dose of CBT-009 drug substance.

Arm Title

CBT-009, Mid Dose

Arm Type

Experimental

Arm Description

CBT-009 mid dose formulation is a proprietary sterile ophthalmic solution that contain mid dose of CBT-009 drug substance.

Arm Title

CBT-009, High Dose

Arm Type

Experimental

Arm Description

CBT-009 high dose formulation is a proprietary sterile ophthalmic solution that contain high dose of CBT-009 drug substance.

Intervention Type

Drug

Intervention Name(s)

CBT-009

Other Intervention Name(s)

Atropine

Intervention Description

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 Type

Drug

Intervention Name(s)

Vehicle

Other Intervention Name(s)

Without Atropine

Intervention Description

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 Type

Drug

Intervention Name(s)

Atropine Sulfate

Other Intervention Name(s)

0.025% eyedrop aqueous solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety on near visual acuity

Description

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

Title

Safety on accommodation

Description

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

Time Frame

28 days

Title

Safety on mesopic and photopic pupil

Description

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

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

36 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tanya Revell, MD

Organizational Affiliation

University of Sunshine Coast，Australia

Official's Role

Principal Investigator

Facility Information:

Facility Name

USC

City

Brisbane

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs