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CSB-001 for Corneal Scar

Phase 1

Recruiting

Research Sponsored by Claris Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eye with a centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at Screening and confirmed at Baseline, and subject reports ability to detect any effect of scar on any element of vision

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 56

Awards & highlights

Study Summary

"This trial will include participants with new corneal scars due to an injury that was detected within the last 30 days and not less than 7 days ago. All participants will receive the experimental treatment

Who is the study for?

This trial is for individuals with new corneal scars from an injury diagnosed within the last 7 to 30 days. Participants will use CSB-001 Ophthalmic Solution, a potential treatment for these scars.Check my eligibility

What is being tested?

The study tests CSB-001 Ophthalmic Solution's safety and effectiveness in treating corneal scars. Subjects apply the solution four times daily for up to two weeks, with follow-up visits extending to Day 56.See study design

What are the potential side effects?

Potential side effects are not specified but may include typical reactions associated with ophthalmic solutions such as eye irritation, redness, discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a scar on my eye close to the center, affecting my vision.

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My eye was injured or infected between 1 to 4 weeks ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety as Assessed by Adverse Event Reporting

Safety as Assessed by Best-Corrected Distance Visual Acuity

Safety as Assessed by Slit-lamp Biomicroscopy

Secondary outcome measures

Efficacy as Assessed by Area of Corneal Scar

Efficacy as Assessed by Contrast Sensitivity

Efficacy as Assessed by Density of Scar

+3 more

Side effects data

From 2015 Phase 4 trial • 157 Patients • NCT02003391

Ocular hyperaemia

Eye pruritus

Nasopharyngitis

Dry eye

Acute tonsillitis

Pharyngitis

Conjunctivitis allergic

Eyelids pruritus

Blepharal pigmentation

Eye irritation

Cataract

Arthritis

Hypersensitivity

Eye pain

Ocular surface disease

100%

80%

60%

40%

20%

Study treatment Arm

DuoTrav

Beta-blocker

Trial Design

1Treatment groups

Experimental Treatment

Group I: CSB-001Experimental Treatment1 Intervention

One drop CSB-001 four times daily for 14 days in the study eye

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Claris Biotherapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing clinical trial?

"As per the details on clinicaltrials.gov, this research study is currently in search of potential participants. The trial was originally published on February 5th, 2024, and last revised on February 6th, 2024."

Answered by AI

What is the total number of subjects enrolled in this research study?

"Indeed, the current information on clinicaltrials.gov shows that this particular medical trial is actively seeking potential participants. This study was originally uploaded on February 5th, 2024 and had its latest update on February 6th, 2024. The research team aims to recruit a total of 20 individuals from one designated location."

Answered by AI

Are individuals who are 50 years of age or older eligible to participate in this clinical trial?

"Recruitment for this study targets individuals above 18 years and below 80 years of age."

Answered by AI

What are the specific goals and objectives of this research study?

"During the 56-day period, this research aims to evaluate safety using slit-lamp biomicroscopy. Secondary objectives consist of assessing efficacy based on corneal scar area determined by slit lamp and anterior segment optical coherence tomography (AS-OCT) imaging, maximum cornea scar depth measured with AS-OCT imaging, and scar volume quantified using AS-OCT imaging."

Answered by AI

Do I meet the requirements to be considered as a potential candidate for this medical study?

"Individuals aged 18 to 80 with corneal scarring are eligible for enrollment in this study, which aims to recruit a cohort of 20 participants."

Answered by AI

Has CSB-001 received FDA clearance for use?

"Given the preliminary nature of this trial, our team at Power rates the safety of CSB-001 as 1 on a scale from 1 to 3. This low rating is due to the limited data available supporting both safety and efficacy in this Phase 1 study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars

2024. "Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06257355.

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