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Active, not recruitingNCT05456425Updated Sep 24, 2025

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

A Phase 3 interventional study of CBT-001 and Vehicle in Pterygium, sponsored by Cloudbreak Therapeutics, LLC. Active, not recruiting at 44 sites in 5 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Cloudbreak Therapeutics, LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
660
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • Pterygium

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03

In context

Pterygium

109 studies on the registry are indexed under Pterygium; 9 are open to participants now.

This study's enrollment of 660 is above the median of 60 across 93 interventional studies indexed under Pterygium.

Browse Pterygium studies →

Lead sponsor

Cloudbreak Therapeutics, LLC is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Pterygium with conjunctival hyperemia

Exclusion criteria

Exclusion Criteria:

Pterygium removal within the last 6 months

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
660 participants (actual)

Study arms

  • Placebo comparator
    Vehicle

    Emulsion eye drop without drug

    Drug: Vehicle

  • Experimental
    CBT-001 Low Dose

    CBT-001 eye drop

    Drug: CBT-001

  • Experimental
    CBT-001 High Dose

    CBT-001 eye drop

    Drug: CBT-001

Interventions

  • DrugCBT-001

    CBT-001 eye drop

  • DrugVehicle

    Formulation without drug

06

What researchers measure

Primary outcomes

  1. conjunctival hyperemia

    Mean difference of conjunctival hyperemia grade change from baseline.

    Time frame: 3 month

  2. pterygium length

    Mean difference of pterygium lesion length change from baseline.

    Time frame: 12 month

07

Study locations

44 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05456425
Lead sponsor
Cloudbreak Therapeutics, LLC
Responsible party
Sponsor
First posted
Jul 13, 2022
Start date
Jun 30, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 24, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Cloudbreak Therapeutics, LLC

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