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

March 29, 2024 updated by: Cloudbreak Therapeutics, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Melbourne
      • East Melbourne, Melbourne, Australia, 3002
        • Recruiting
        • The Centre for Eye Research Australia
        • Contact:
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Recruiting
        • Eyeclinic Albury Wodonga
        • Contact:
    • Victoria
      • St Albans, Victoria, Australia, 3021
        • Recruiting
        • Sunshine Eye Surgeons
        • Contact:
  • China
      • Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital; CMU
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Haikou, China, 570311
        • Recruiting
        • Hainan Provincial Eye Hospital
        • Contact:
      • Hengyang, China, 421001
        • Recruiting
        • 1st Affiliated Hospital of University of South China
        • Contact:
      • Kunming, China, 650021
        • Recruiting
        • The Second People's Hospital of Yunnan Province
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • The First Affiliated Hospital of NC University
        • Contact:
      • Qingdao, China, 250021
        • Recruiting
        • Eye Hospital of Shandong First Medical University
        • Contact:
      • Wenzhou, China, 325027
        • Recruiting
        • Eye Hospital of Wenzhou Medical University
        • Contact:
      • Wuhan, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College
        • Contact:
      • Xiamen, China, 361004
        • Recruiting
        • Xiamen Eye Center of Xiamen University
        • Contact:
  • India
      • Chandigarh, India, 160012
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Recruiting
        • Netralaya Super Specialty Eye Hospital
        • Contact:
      • Ahmedabad, Gujarat, India, 380016
    • Karnataka
      • Bangalore, Karnataka, India, 560010
        • Recruiting
        • Narayana Nethralaya
        • Contact:
    • Maharashtra
      • Nashik, Maharashtra, India, 422005
    • Odisha
      • Bhubaneswar, Odisha, India, 751024
    • Rajasthan
      • Bīkaner, Rajasthan, India, 334001
    • Uttar Pradesh
      • Noida, Uttar Pradesh, India, 201301
  • New Zealand
      • Auckland, New Zealand, 1050
      • Auckland, New Zealand, 1050
      • Christchurch, New Zealand, 8013
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Cornea and Cataract Consultants of Arizona
        • Contact:
          • Jung Dao, MD
      • Sun City, Arizona, United States, 83531
        • Recruiting
        • Walman Eye Center
        • Contact:
          • Gerald Walman, MD
    • California
      • Bakersfield, California, United States, 93308
        • Recruiting
        • Bakersfield Eye Institute
        • Contact:
          • David Hair, MD
      • Bakersfield, California, United States, 93311
        • Recruiting
        • West Coast Eye Institute
        • Contact:
          • Sandeep Walia, MD
      • Glendale, California, United States, 91204
        • Recruiting
        • Global Research Mangement
        • Contact:
          • Sherif El-Harazi, MD
      • Hemet, California, United States, 92545
        • Recruiting
        • Inland Eye Specialists
        • Contact:
          • Robert Sorenson, MD
      • Northridge, California, United States, 91325
        • Recruiting
        • Shultz Chang Vision
        • Contact:
          • Mitchell Shultz, MD
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Santa Barbara Eye Care
        • Contact:
          • Douglas Katsev, MD
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Recruiting
        • Bruce A. Segal, MD
        • Contact:
          • Bruce A Segal, MD
      • Tampa, Florida, United States, 33603
        • Recruiting
        • International Research Center
        • Contact:
          • Bernard Perez, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Recruiting
        • The Eye Care Institute
        • Contact:
          • John Meyer, MD
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Clinic Eye Specialists
        • Contact:
          • Shachar Tauber, MD
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Center For Sight
        • Contact:
          • Eva Liang, MD
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Wellish Vision Institute
        • Contact:
          • Kent Wellish, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • Vance Thompson Vision
        • Contact:
          • Daniel Terveen, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
          • Masih Ahmed, MD
      • McAllen, Texas, United States, 78572
        • Recruiting
        • DCT-Shah Research, LLC dba Discovery Clinical Trials
        • Contact:
          • Pankajkumar G. Shah
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • R and R Eye Research, LLC
        • Contact:
          • Gregory Brunin, MD
    • Virginia
      • Falls Church, Virginia, United States, 22046
        • Recruiting
        • Emerson Clinical Research Institute, LLC
        • Contact:
          • Gustavo Corrales, MD
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Wagner Macula & Retina Center
        • Contact:
          • Kapil Kapoor, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Pterygium with conjunctival hyperemia

Exclusion Criteria:

Pterygium removal within the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Emulsion eye drop without drug
Drug: Vehicle
Formulation without drug
Experimental: CBT-001 Low Dose
CBT-001 eye drop
Drug: CBT-001
CBT-001 eye drop
Experimental: CBT-001 High Dose
CBT-001 eye drop
Drug: CBT-001
CBT-001 eye drop

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cloudbreak Therapeutics, LLC

Investigators

  • Principal Investigator: Bruce A Segal, ND, Bruce A. Segal, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 9, 2022

First Submitted That Met QC Criteria

July 9, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT-CS301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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