RECRUITING

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency

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

This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or both study eyes. The study is comprised of two identical phases (Dosing Phase I and II) of test article dosing separated by a 31- to 40-day period, the Dosing Holiday, where no test article is administered. Dosing Phase II is followed by an observational, noninterventional phase (Observation Phase).

Official Title

An Open-Label Study to Evaluate the Safety and Efficacy of Two CSB-001 Ophthalmic Solution 0.1% Dosing Regimens in Subjects With Limbal Stem Cell Deficiency

Quick Facts

Study Start:2024-05-15
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06452316

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have an area of the central 5 mm zone of cornea affected, presence of at least one clinical sign observed by slit-lamp examination with white light and/or cobalt blue light, fluorescein, and a Wratten filter, and at least one clinical sign observed with AS-OCT.
  2. * If dosing with Acthar at time of Screening Visit, must have a history of stable dosing for approximately 8 weeks, plan to maintain the same Acthar treatment dose and regimen, and have demonstrated little to no improvement in severity of LSCD.
  3. * Sponsor written confirmation of qualifying LSCD diagnosis.
  4. * Inflammation associated with LSCD or other non-infectious inflammation that will not interfere with subject's participation.
  1. * Any active ocular infection (bacterial, viral, fungal, or protozoan) in either eye.
  2. * Ocular surgery within 30 days of Day 0 where investigator assesses that healing is not considered complete/stable.
  3. * Planned ocular surgery on or before Week 20 visit.
  4. * Presence or history of any ocular or systemic disorder, condition, or procedure that might hinder the efficacy of the study treatment or its evaluation, or could interfere with the interpretation of study results, in the opinion of the investigator.

Contacts and Locations

Study Contact

Central Operations Representative
CONTACT
919-354-1299
clinicaltrials@clarisbio.com

Study Locations (Sites)

Loma Linda University Eye Institute
Loma Linda, California, 92354
United States
Midwest Cornea Associates, LLC
Carmel, Indiana, 46290
United States
Francis Price Jr, MD
Indianapolis, Indiana, 46260
United States
Minnesota Eye Consultants
Minnetonka, Minnesota, 55305
United States
Legacy Devers Eye Institute
Portland, Oregon, 97210
United States
Stuart A. Terry, MD PA
San Antonio, Texas, 78212
United States

Collaborators and Investigators

Sponsor: Claris Biotherapeutics, Inc.

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 Date2024-05-15
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-05-15
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Limbal Stem Cell Deficiency