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

Multicenter, Double-Masked, Randomized, Vehicle-Controlled 12-Month Parallel Comparison of the Safety and Efficacy of 0.1% and 0.2% CBT-001 Versus Vehicle, Dosed Twice-Daily, in Patients With Pterygium

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05456425

Enrollment

660

Registered

2022-07-13

Start date

2022-06-30

Completion date

2027-12-31

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pterygium

Brief 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.

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.

Interventions

DRUGCBT-001

CBT-001 eye drop

DRUGVehicle

Formulation without drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Multicenter, Double-Masked, Randomized, Vehicle-Controlled Parallel Comparison with dosing twice-daily in eye(s) with pterygium

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

Pterygium with conjunctival hyperemia

Exclusion criteria

Pterygium removal within the last 6 months

Design outcomes

Primary

Measure	Time frame	Description
conjunctival hyperemia	3 month	Mean difference of conjunctival hyperemia grade change from baseline.
pterygium length	12 month	Mean difference of pterygium lesion length change from baseline.

Countries

Australia, China, India, New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026