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ACTIVE NOT RECRUITING Phase 3

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

NCT05456425 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Vehicle
  • DRUG CBT-001

Study Locations (20)

California

  • West Coast Eye Institute — Bakersfield
  • Global Research Mangement — Glendale
  • Inland Eye Specialists — Hemet
  • Eye Research Foundation — Newport Beach
  • Shultz Chang Vision — Northridge
  • North Bay Eye Associates INC — Petaluma
  • Santa Barbara Eye Care — Santa Barbara

Texas

  • Baylor College of Medicine — Houston
  • DCT-Shah Research, LLC dba Discovery Clinical Trials — McAllen
  • Clinical Trials of Texas — San Antonio
  • R and R Eye Research — San Antonio

Florida

  • Advanced Research; LLC — Deerfield Beach
  • Bruce A. Segal, MD — Delray Beach
  • International Research Center — Tampa

Alabama

  • Trinity Research Group — Dothan

Arizona

  • Horizon Eye Specialists & LASIK Center — Sun City

Kentucky

  • The Eye Care Institute — Louisville

Nevada

  • Center for Sight — Henderson

South Dakota

  • Vance Thompson Vision — Sioux Falls

Trial Details

FieldValue
Enrollment Target 660 participants
Start Date 2022-06-30
Est. Completion 2027-12-31
Phase Phase 3

Sponsor

Cloudbreak Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05456425

The ClinicalTrials.gov registry entry for NCT05456425 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cloudbreak Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pterygium appearing as the primary indexed condition, and to 2 interventions — of which Vehicle is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05456425 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05456425 about?

NCT05456425 is a clinical study titled "A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium". 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.

What is the current status of trial NCT05456425?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2022-06-30. Estimated completion is 2027-12-31.

What conditions does trial NCT05456425 study?

This clinical trial studies the following conditions: Pterygium. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05456425?

The interventions under investigation include: Vehicle (DRUG), CBT-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05456425?

This trial is sponsored by Cloudbreak Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05456425 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial