Evaluating a new eye treatment for Limbal Stem Cell Deficiency
Official title: An Open-Label Study Evaluating the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
Run by Claris Biotherapeutics, Inc. · NCT06452316 · Data updated 2026-11-12
This study is testing a new eye drop treatment for people with Limbal Stem Cell Deficiency to see if it is safe and helps improve their condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Claris Biotherapeutics, Inc. Industry-sponsored |
| Locations | 6 sites (Loma Linda, California and 5 other locations) |
| Status | Recruiting |
| Started | May 15, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT06452316 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with Limbal Stem Cell Deficiency who exhibit specific clinical signs and have not shown improvement with current treatments.
✕Probably not a fit
Patients with active ocular infections or those who have had recent ocular surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the safety and efficacy of CSB-001, an ophthalmic solution, in patients suffering from Limbal Stem Cell Deficiency (LSCD). Participants will receive the investigational drug in one or both eyes over two dosing phases, separated by a period without treatment. The study includes an observational phase following the dosing phases to monitor outcomes. The trial is designed to gather data on the drug's effectiveness and safety profile in this specific patient population.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients with Limbal Stem Cell Deficiency.
How similar studies have gone: While there have been studies on similar treatments for LSCD, the specific approach of using CSB-001 is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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. Note: Other inclusion/exclusion criteria apply.
Where it's running
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Loma Linda University Eye Institute
Loma Linda, California, United States Recruiting -
Midwest Cornea Associates, LLC
Carmel, Indiana, United States Recruiting -
Francis Price Jr, MD
Indianapolis, Indiana, United States Recruiting -
Minnesota Eye Consultants
Minnetonka, Minnesota, United States Recruiting -
Legacy Devers Eye Institute
Portland, Oregon, United States Recruiting -
Stuart A. Terry, MD PA
San Antonio, Texas, United States Recruiting
Study contacts
- Study coordinator: Central Operations Representative
- Email: clinicaltrials@clarisbio.com
- Phone: 949-354-1299
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Limbal Stem Cell Deficiency: Observational Look at How It Manages Over Time
This study follows people with limbal stem cell deficiency to see how the condition progresses and how care is managed over time, without giving any experimental treatment.
-
Limbal function and tear protein changes in glaucoma
This study tests whether glaucoma and long-term glaucoma medicines change limbal stem cell–related corneal epithelial thickness and tear proteins in people with glaucoma, ocular hypertension, or healthy adults.
-
Using cultured corneal cells to treat limbal stem cell deficiency
This study is testing if transplanting specially grown corneal cells can help people with limbal stem cell deficiency improve their eye health and vision.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.