RECRUITING

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

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).

Conditions

Limbal Stem Cell Deficiency
Talk to us

Related Conditions:

Limbal Stem Cell Deficiency

Study Overview

On this page

Study Details

Study overview

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).

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

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

Condition
Limbal Stem Cell Deficiency
Intervention / Treatment

-

Contacts and Locations

Loma Linda

Loma Linda University Eye Institute, Loma Linda, California, United States, 92354

Carmel

Midwest Cornea Associates, LLC, Carmel, Indiana, United States, 46290

Indianapolis

Francis Price Jr, MD, Indianapolis, Indiana, United States, 46260

Minnetonka

Minnesota Eye Consultants, Minnetonka, Minnesota, United States, 55305

Portland

Legacy Devers Eye Institute, Portland, Oregon, United States, 97210

San Antonio

Stuart A. Terry, MD PA, San Antonio, Texas, United States, 78212

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.
  • * Sponsor written confirmation of qualifying LSCD diagnosis.
  • * Inflammation associated with LSCD or other non-infectious inflammation that will not interfere with subject's participation.
  • * Any active ocular infection (bacterial, viral, fungal, or protozoan) in either eye.
  • * Ocular surgery within 30 days of Day 0 where investigator assesses that healing is not considered complete/stable.
  • * Planned ocular surgery on or before Week 20 visit.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Claris Biotherapeutics, Inc.,

Study Record Dates

2025-08