Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects
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| ClinicalTrials.gov Identifier: NCT04909450 |
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Recruitment Status :
Recruiting
First Posted : June 1, 2021
Last Update Posted : June 7, 2023
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Sponsor:
Claris Biotherapeutics, Inc.
Information provided by (Responsible Party):
Claris Biotherapeutics, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neurotrophic Keratitis | Biological: CSB-001 Ophthalmic Solution 0.1% Biological: Vehicle Control | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 108 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | August 24, 2021 |
| Estimated Primary Completion Date : | November 2023 |
| Estimated Study Completion Date : | February 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Keratitis-ichthyosis-deafness syndrome
| Arm | Intervention/treatment |
|---|---|
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Experimental: CSB-001 Investigational Treatment Arm
One drop CSB-001 four times daily for 8 weeks in the study eye
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Biological: CSB-001 Ophthalmic Solution 0.1%
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor) |
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Placebo Comparator: Vehicle Control Arm
One drop matching vehicle four times daily for 8 weeks in the study eye
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Biological: Vehicle Control
Matching vehicle control without the drug substance |
Primary Outcome Measures :
- Efficacy as Assessed by Complete Corneal Healing [ Time Frame: Week 8 through Week 10 ]Proportion of subjects achieving complete corneal healing as assessed by the Central Reading Center
- Safety as Assessed by Adverse Event Reporting [ Time Frame: Screening through Week 10 ]Incidence of ocular and systemic adverse events
- Safety as Assessed by Slit-lamp Biomicroscopy [ Time Frame: Screening through Week 10 ]Change from baseline in staining using NEI scale (0 = absent to 3 = severe for 5 areas of the cornea) with Grade 0 (no staining) to maximum of Grade 15
- Safety as Assessed by Intraocular Pressure [ Time Frame: Screening through Week 10 ]Change in baseline in intraocular pressure using the Goldmann tonometry
- Safety as Assessed by Dilated Fundus Examination [ Time Frame: Screening through Week 10 ]Change from baseline in observed anomalies of the peripheral retina, macula, choroid, optic nerve and vitreous (cup/disc ratio)
- Safety as Assessed by Best-Corrected Distance Visual Acuity [ Time Frame: Screening through Week 10 ]Change from baseline using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart
Secondary Outcome Measures :
- Efficacy as Assessed by Corneal Healing [ Time Frame: Week 1 through Week 10 ]Time to corneal healing based on assessments by the Central Reading Center
- Efficacy as Assessed by Corneal Healing at Week 4 [ Time Frame: Week 1 through Week 4 ]Proportion of subjects achieving corneal healing at Week 4 assessed by the Central Reading Center
- Efficacy as Assessed by Corneal Healing at Week 4 and Week 8 Sustained for Two Weeks [ Time Frame: Weeks 4 and 8 through Week 10 ]Proportion of subjects achieving corneal healing at Week 4 and Week sustained for 2 weeks as assessed by the investigator
- Efficacy as Assessed by Decrease in Lesion Size [ Time Frame: Week 1 through Week 10 ]Time to ≥20% decrease in lesion size (maximum diameter) from baseline assessed by the Central Reading Center
- Efficacy as Assessed by Time to Corneal Healing [ Time Frame: Week 1 through Week 10 ]Time to corneal healing based on assessments by the investigator
- Efficacy as Assessed by Best Corrected Distance Visual Acuity [ Time Frame: Week 1 through Weeks 4 and 8 ]Proportion of subjects achieving a ≥15-letter gain in the study eye from baseline in Best Corrected Distance Visual Acuity
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Note: Other inclusion/exclusion criteria apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909450
Contacts
| Contact: Clinical Operations Representative | 919-205-0012 | clinicaltrials@clarisbio.com |
Locations
Show 45 study locations
Sponsors and Collaborators
Claris Biotherapeutics, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Claris Biotherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04909450 |
| Other Study ID Numbers: |
CSB-C20-003 |
| First Posted: | June 1, 2021 Key Record Dates |
| Last Update Posted: | June 7, 2023 |
| Last Verified: | June 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Keratitis Corneal Diseases Eye Diseases Ophthalmic Solutions Pharmaceutical Solutions |