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Ophthalmic Solution

CSB-001 Eye Drops for Neurotrophic Keratitis

Phase 1 & 2
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
Subjects with stage 2 (PED) or stage 3 (corneal ulcer) neurotrophic keratitis (NK)
Subjects with clinical evidence of decreased corneal sensitivity within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4 and 8 through week 10
Awards & highlights

Study Summary

This trial will enroll people with moderate to severe neurotrophic keratitis. Half the participants will receive a daily eye drop of an experimental medication, while the other half will receive a placebo drop. Everyone will be monitored for 8 weeks to see if their neurotrophic keratitis improves.

Who is the study for?
This trial is for people with moderate to severe neurotrophic keratitis, which affects the cornea of the eye. Participants must have shown no improvement despite standard treatments and be willing to follow study procedures. They can't join if they've used Oxervate recently, have other eye diseases needing treatment during the study (except controlled glaucoma), or any active infections in their eyes.Check my eligibility
What is being tested?
The trial tests CSB-001 Ophthalmic Solution against a placebo control. Participants are randomly chosen to receive either the test medication or placebo, applying it four times daily for 8 weeks with weekly clinic visits. Those on placebo without healing may later try the actual drug in an open-label phase.See study design
What are the potential side effects?
While specific side effects aren't listed here, ophthalmic solutions like CSB-001 can typically cause eye irritation, redness, discomfort or blurred vision temporarily after application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have stage 2 or 3 neurotrophic keratitis.
Select...
I have reduced feeling in my eye's cornea, both where there is damage and in other parts.
Select...
My eye condition hasn't improved in 2 weeks despite treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4 and 8 through week 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4 and 8 through week 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy as Assessed by Complete Corneal Healing
Safety as Assessed by Adverse Event Reporting
Safety as Assessed by Best-Corrected Distance Visual Acuity
+3 more
Secondary outcome measures
Efficacy as Assessed by Best Corrected Distance Visual Acuity
Efficacy as Assessed by Corneal Healing
Efficacy as Assessed by Corneal Healing at Week 4
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CSB-001 Investigational Treatment ArmExperimental Treatment1 Intervention
One drop CSB-001 four times daily for 8 weeks in the study eye
Group II: Vehicle Control ArmPlacebo Group1 Intervention
One drop matching vehicle four times daily for 8 weeks in the study eye

Find a Location

Who is running the clinical trial?

Claris Biotherapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

CSB-001 Ophthalmic Solution 0.1% (Ophthalmic Solution) Clinical Trial Eligibility Overview. Trial Name: NCT04909450 — Phase 1 & 2
Neurotrophic Keratitis Research Study Groups: CSB-001 Investigational Treatment Arm, Vehicle Control Arm
Neurotrophic Keratitis Clinical Trial 2023: CSB-001 Ophthalmic Solution 0.1% Highlights & Side Effects. Trial Name: NCT04909450 — Phase 1 & 2
CSB-001 Ophthalmic Solution 0.1% (Ophthalmic Solution) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04909450 — Phase 1 & 2
Neurotrophic Keratitis Patient Testimony for trial: Trial Name: NCT04909450 — Phase 1 & 2

Frequently Asked Questions

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

Are researchers currently recruiting people for this experiment?

"The trial is, as of right now, looking for potential participants. The study was first posted on 8/24/2021 and was last updated on 10/21/2022. 31 different locations are being used in order to find the 108 patients needed."

Answered by AI

In how many different hospitals is this treatment protocol open to patients?

"This trial is presently running at 31 sites. The locations are based in Toronto, Torrance and Atlanta along with other locations 31 other locations. If you are thinking about participating, please choose the clinic nearest you to minimize travel demands."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Florida
Colorado
Other
How old are they?
18 - 65
What site did they apply to?
Vision Institute
Eye Consultants of Atlanta
Other
Metropolitan Eye Research and Surgery Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I am interested in a clinical study. I have tried Oxervate and was very faithful, worked for about 1 month now back to the beginning.
PatientReceived 2+ prior treatments
Recent research and studies
CorneaJournal
Cutting Edge: Topical Recombinant Nerve Growth Factor for the Treatment of Neurotrophic Keratopathy—biologicals as a Novel Therapy for Neurotrophic Keratopathy
Hamrah, Pedram, Leyla Yavuz Saricay, and M. Cuneyt Ozmen. 2022. “Cutting Edge: Topical Recombinant Nerve Growth Factor for the Treatment of Neurotrophic Keratopathy—biologicals as a Novel Therapy for Neurotrophic Keratopathy”. Cornea. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ico.0000000000002974.
clinicaltrials.govStudy
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects
2021. "Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04909450.
~35 spots leftby Apr 2025
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