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

C

Cloudbreak Therapeutics

Status and phase

Enrolling
Phase 3

Conditions

Pterygium

Treatments

Drug: Vehicle
Drug: CBT-001

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: 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. 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

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

Trial contacts and locations

44

Loading...

Central trial contact

Kimberly Root, BA; Abu Abraham, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems