ACTIVE_NOT_RECRUITING

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

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Conditions

Pterygium

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-30
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05456425

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Trinity Research Group
Dothan, Alabama, 36301
United States
Horizon Eye Specialists & LASIK Center
Sun City, Arizona, 83531
United States
West Coast Eye Institute
Bakersfield, California, 93311
United States
Global Research Mangement
Glendale, California, 91204
United States
Inland Eye Specialists
Hemet, California, 92545
United States
Eye Research Foundation
Newport Beach, California, 92663
United States
Shultz Chang Vision
Northridge, California, 91325
United States
North Bay Eye Associates INC
Petaluma, California, 94954
United States
Santa Barbara Eye Care
Santa Barbara, California, 93105
United States
Advanced Research; LLC
Deerfield Beach, Florida, 33064
United States
Bruce A. Segal, MD
Delray Beach, Florida, 33484
United States
International Research Center
Tampa, Florida, 33603
United States
The Eye Care Institute
Louisville, Kentucky, 40206
United States
Center for Sight
Henderson, Nevada, 89052
United States
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
DCT-Shah Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78572
United States
Clinical Trials of Texas
San Antonio, Texas, 78229
United States
R and R Eye Research
San Antonio, Texas, 78229
United States
Emerson Clinical Research Institute, LLC
Falls Church, Virginia, 22046
United States

Collaborators and Investigators

Sponsor: Cloudbreak Therapeutics, LLC

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 Registration Dates

Study Start Date2022-06-30
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-06-30
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pterygium