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RecruitingPhase 1

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

Claris Biotherapeutics, Inc. · NCT06452316

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
75
US sites recruiting
6
Study start
May 15, 2024
Record last updated
August 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: CSB-001 Ophthalmic Solution 0.1%

Conditions: Limbal Stem Cell Deficiency

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Loma Linda University Eye Institute

    Loma Linda, CA 92354

    Site contact: Study Coordinator

  • Midwest Cornea Associates, LLC

    Carmel, IN 46290

    Site contact: Study Coordinator

  • Francis Price Jr, MD

    Indianapolis, IN 46260

    Site contact: Study Coordinator

  • Minnesota Eye Consultants

    Minnetonka, MN 55305

    Site contact: Study Coordinator

  • Legacy Devers Eye Institute

    Portland, OR 97210

    Site contact: Study Coordinator

  • Stuart A. Terry, MD PA

    San Antonio, TX 78212

    Site contact: Study Coordinator

Study contacts (from the official record)

  • Central Operations Representative · 949-354-1299 · clinicaltrials@clarisbio.com
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