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RECRUITING Phase 1

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

NCT06452316 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • BIOLOGICAL CSB-001 Ophthalmic Solution 0.1%

Study Locations (6)

Indiana

  • Midwest Cornea Associates, LLC — Carmel
  • Francis Price Jr, MD — Indianapolis

California

  • Loma Linda University Eye Institute — Loma Linda

Minnesota

  • Minnesota Eye Consultants — Minnetonka

Oregon

  • Legacy Devers Eye Institute — Portland

Texas

  • Stuart A. Terry, MD PA — San Antonio

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2024-05-15
Est. Completion 2026-05
Phase Phase 1

Sponsor

Claris Biotherapeutics

33 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06452316

The ClinicalTrials.gov registry entry for NCT06452316 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Claris Biotherapeutics, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Limbal Stem Cell Deficiency appearing as the primary indexed condition, and to 1 intervention — of which CSB-001 Ophthalmic Solution 0.1% is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06452316 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Indiana, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06452316 about?

NCT06452316 is a clinical study titled "Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency". 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 peri...

What is the current status of trial NCT06452316?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2024-05-15. Estimated completion is 2026-05.

What conditions does trial NCT06452316 study?

This clinical trial studies the following conditions: Limbal Stem Cell Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06452316?

The interventions under investigation include: CSB-001 Ophthalmic Solution 0.1% (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06452316?

This trial is sponsored by Claris Biotherapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06452316 being conducted?

This trial has 6 study locations across California, Indiana, Minnesota, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial