MedTrace Logo

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

NCT05456425 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2025-09-24

No results posted yet for this 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.

Conditions

  • Pterygium

Interventions

DRUG

CBT-001

CBT-001 eye drop

DRUG

Vehicle

Formulation without drug

Sponsors & Collaborators

  • Cloudbreak Therapeutics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • India
  • New Zealand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456425 on ClinicalTrials.gov