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Tests treatment safety and results for Limbal Stem Cell Deficiency
Official title Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
ClinicalTrials.gov ID: NCT06452316
What this study is testing
What is CSB-001 Ophthalmic Solution 0.1%?
CSB-001 Ophthalmic Solution 0.1% is an investigational medicine, being studied as a potential treatment for limbal stem cell deficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Sponsor written confirmation of qualifying LSCD diagnosis.
- Inflammation associated with LSCD or other non-infectious inflammation that will not interfere with subject's participation.
You likely can't join if
- 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 how well it works of the study treatment or its...
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- Carmel, Indiana, United States
- Indianapolis, Indiana, United States
- Minnetonka, Minnesota, United States
- Portland, Oregon, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; Carmel, Indiana, United States; Indianapolis, Indiana, United States; Minnetonka, Minnesota, United States; Portland, Oregon, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.