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A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium

PHASE3RECRUITING

The objective is to evaluate the safety and efficacy of low dose and high dose CBT-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.

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Study details:

Clinical Hypotheses:. 1. CBT-001 dosed twice daily is more effective than vehicle in:.

* Reducing conjunctival hyperemia by demonstrating a statistically significant difference and clinically relevant improvement in the mean severity grade change from baseline. * Preventing pterygium progression, by demonstrating a statistically significant and clinically relevant improvement on drug vs vehicle mean difference in the change in pterygium length from baseline. 2.

CBT-001 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Pterygium with conjunctival hyperemia
  • Exclusion criteria

  • Pterygium removal within the last 6 months
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    Eligibility

    Age eligible for study : 12 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-06-30

    Primary completion: 2025-12-31

    Study completion finish: 2026-12-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT05456425

    Intervention or treatment

    DRUG: CBT-001

    DRUG: Vehicle

    Conditions

    • Pterygium

    Find a site

    Closest Location:

    The Centre for Eye Research Australia

    Research sites nearby

    Select from list below to view details:

    • The Centre for Eye Research Australia

      East Melbourne, Melbourne, Australia

    • Eyeclinic Albury Wodonga

      Albury, New South Wales, Australia

    • Sunshine Eye Surgeons

      St Albans, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    PLACEBO_COMPARATOR: Vehicle
    • Emulsion eye drop without drug
    DRUG: Vehicle
    • Formulation without drug
    EXPERIMENTAL: CBT-001 Low Dose
    • CBT-001 eye drop
    DRUG: CBT-001
    • CBT-001 eye drop
    EXPERIMENTAL: CBT-001 High Dose
    • CBT-001 eye drop
    DRUG: CBT-001
    • CBT-001 eye drop

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    conjunctival hyperemiaMean difference of conjunctival hyperemia grade change from baseline.3 month
    pterygium lengthMean difference of pterygium lesion length change from baseline.12 month

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium

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