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Tests treatment safety and results for Corneal Scar
Official title Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
ClinicalTrials.gov ID: NCT06257355
What this study is testing
What is CSB-001 Ophthalmic Solution 0.1%?
CSB-001 Ophthalmic Solution 0.1% is an investigational medicine, given as an once-daily, being studied as a potential treatment for corneal scar.
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 recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1.
- 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 to 80
You may be able to join if
- Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately...
- Eye with a recent corneal insult approximately ≤30 days and ≥7 days from the Screening Visit.
- Corneal insult includes but is not limited to mechanical / chemical / thermal injury, bacterial keratitis, PRK, and contact lens related ulcer.
- Eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing...
- people must have the ability and willingness to comply with study procedures.
You likely can't join if
- Corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by ASOCT image at the Screening Visit.
- Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images.
- No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images.
- Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. people with...
- Ocular surgery planned during the study treatment period.
- 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
- Norfolk, Virginia, 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 to 80 years. 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 and 1 more location(s). 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.