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

Cloudbreak Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Pterygium

Treatments: Drug: CBT-001; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT05456425

CBT-CS301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Pterygium with conjunctival hyperemia

Exclusion criteria

Pterygium removal within the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 3 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Emulsion eye drop without drug

Treatment:

Drug: Vehicle

CBT-001 Low Dose

Experimental group

Description:

CBT-001 eye drop

Treatment:

Drug: CBT-001

CBT-001 High Dose

Experimental group

Description:

CBT-001 eye drop

Treatment:

Drug: CBT-001