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Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects

A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects

NCT04909450•Claris Biotherapeutics, Inc.

View on ClinicalTrials.gov

Summary

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with stage 2 (PED) or stage 3 (corneal ulcer) neurotrophic keratitis (NK). Subjects with bilateral NK may enroll in the study but only one eye will be selected as the study eye (worse eye) and be treated with test article.
•Subjects with no clinical evidence of improvement in the PED or corneal ulcer within the 2 weeks prior to study enrollment despite the use of conventional non-surgical treatments for neurotrophic keratitis (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops and medications that can decrease corneal sensitivity; therapeutic contact lenses \[either silicone hydrogel or rigid gas permeable\]) as determined by the investigator or referring physician's medical record.
•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 in the opinion of the investigator assessed with a cotton wisp.
•Pinhole distance visual acuity score ≤ 75 ETDRS letters measured with a LogMAR chart (≥ 0.2 LogMAR, ≤ 20/32 Snellen or worse Snellen or ≤ 0.625 decimal fraction) in the study eye.
•Subjects must have the ability and willingness to comply with study procedures.

Exclusion Criteria

•Any active ocular infection (bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in either eye in the opinion of the investigator. Infectious epithelial keratitis including herpetic keratitis (i.e., dendritic lesions or geographic ulcers) in either eye is excluded. Subjects on oral antibiotic at the time of screening are eligible but should continue the medication for the duration of the study.
•Previous use of Oxervate in the study eye with last administration within the past 2 months.
•Any other ocular disease, except glaucoma, that will require topical ocular treatment in the study eye over the course of the study.
•Use of any other topical treatments other than the study medication provided by the Sponsor and allowed by the study protocol can be administered to the study eye over the course of the study. The following are exceptions: a) Allowance for use of preservative-free antibiotic eye drops if prescribed by the investigator and b) Allowance for use of a non-preserved IOP-lowering prostaglandin topical ocular drop administered once-daily (QD) in glaucomatous eyes over the course of the study.

Locations (48)

Eye Care North

Cave Creek, Arizona, United States

Loma Linda University Eye Institute

Loma Linda, California, United States

Nvision Clinical Research, LLC

Los Angeles, California, United States

Global Research Foundation

Los Angeles, California, United States

UCLA Stein Eye Institute

Los Angeles, California, United States

LoBue Laser and Eye Medical Center, Inc.

Murrieta, California, United States

California Eye Specialists Medical Group Inc.

Pasadena, California, United States

Martel Eye Medical Group

Rancho Cordova, California, United States

Gordon Schanzlin New Vision Institute

San Diego, California, United States

Atlantis Eyecare

Torrance, California, United States

Key Dates

Start Date

August 24, 2021

Primary Completion Date

May 7, 2024

Completion Date

June 4, 2024

Last Updated

September 19, 2024

Enrollment

131

ACTUAL participants

Conditions

Neurotrophic Keratitis

Interventions

CSB-001 Ophthalmic Solution 0.1%

BIOLOGICAL

Vehicle Control

BIOLOGICAL

A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis

NCT06999733

Neurotrophic Keratitis

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RECRUITING

OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

NCT04573647

Neurotrophic UlcerNeurotrophic Keratitis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects

Inclusion Criteria

Exclusion Criteria

A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis

OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate

REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients

Corneal Nerves After Treatment With Cenegermin

Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis

Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.