What side effects are associated with this type of intervention?

Common treatments for corneal scars, such as topical cyclosporine A and other ophthalmic solutions, generally aim to promote corneal healing and reduce scar formation. Side effects of these treatments can include conjunctival injection, stinging, and eyelid maceration. In some cases, treatments like cyclosporine A have shown no significant inhibition of epithelial or stromal corneal wound healing but may cause mild instillation site pain. Other treatments, such as corticosteroids, may retard epithelial healing and increase the risk of complications like elevated intraocular pressure and cataract formation with prolonged use.

What prior FDA approvals exist?

There is limited specific information on FDA-approved drugs solely for the treatment of corneal scars. However, treatments that promote corneal healing and reduce scar formation include various topical corticosteroids and antibiotics. These treatments are often used to manage corneal epithelial defects and other corneal injuries, which can indirectly aid in reducing scar formation. The investigational drug CSB-001, currently being studied, aims to promote corneal healing and reduce scar formation, representing a potential future option pending further clinical trials and FDA approval.

What other types of research exist?

Promising alternatives to CSB-001 for corneal scar treatment include: 1) Topical fibronectin and aprotinin, although initial studies in rabbits did not show significant benefits, further research may optimize their use. 2) Keratinocyte Growth Factor-2 (KGF-2), which has shown potential in accelerating corneal epithelial wound healing in alkali-injured rabbit models. 3) Beremagene geperpavec (B-VEC), a gene therapy that has demonstrated efficacy in wound healing in dystrophic epidermolysis bullosa, may have potential applications in corneal healing.

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CSB-001 Ophthalmic Solution 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

Must not have

Ocular surgery planned during the study treatment period

No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 56

Awards & highlights

No Placebo-Only Group

Summary

This trial tests CSB-001 eye drops on people with new corneal scars. The drops are applied regularly to help heal the scars.

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.

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.

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

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am scheduled for eye surgery during the study.

Select...

My eye scar is not near the center of my cornea.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety as Assessed by Adverse Event Reporting

Safety as Assessed by Best-Corrected Distance Visual Acuity

Safety as Assessed by Slit-lamp Biomicroscopy

Secondary study objectives

Efficacy as Assessed by Area of Corneal Scar

Efficacy as Assessed by Contrast Sensitivity

Efficacy as Assessed by Density of Scar

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: CSB-001 TIDExperimental Treatment1 Intervention

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

Group II: CSB-001 QIDExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CSB-001 Ophthalmic Solution 0.1%

2021

Completed Phase 2

~140

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for corneal scars, such as the investigational CSB-001 ophthalmic solution, typically work by promoting corneal healing and reducing scar formation. These treatments often involve the use of growth factors, anti-inflammatory agents, or extracellular matrix proteins that facilitate the regeneration of corneal tissue and minimize fibrotic scarring. For instance, keratinocyte growth factor-2 (KGF-2) has been shown to enhance corneal epithelial healing by stimulating the proliferation of epithelial stem cells. Similarly, treatments like TGF-beta1 can modulate the expression of integrins, which are crucial for cell adhesion and wound healing. These mechanisms are vital for corneal scar patients as they help restore corneal transparency and improve vision, thereby significantly enhancing the quality of life.

Expression of tenascin and fibronectin in the rabbit cornea after excimer laser surgery.[Effect of TGF-beta1 on expression of integrin beta1 following corneal alkali burns in rabbits].Keratinocyte growth factor-2 on the proliferation of corneal epithelial stem cells in rabbit alkali burned cornea.