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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04909450
Other study ID # CSB-C20-003
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 24, 2021
Est. completion date July 2024

Study information

Verified date February 2024
Source Claris Biotherapeutics, Inc.
Contact Clinical Operations Representative
Phone 919-205-0012
Email clinicaltrials@clarisbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CSB-001 Ophthalmic Solution 0.1%
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Vehicle Control
Matching vehicle control without the drug substance

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Sponsors (1)

Lead Sponsor Collaborator
Claris Biotherapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy as Assessed by Complete Corneal Healing Proportion of subjects achieving complete corneal healing as assessed by the Central Reading Center Week 8 through Week 10
Primary Safety as Assessed by Adverse Event Reporting Incidence of ocular and systemic adverse events Screening through Week 10
Primary Safety as Assessed by Slit-lamp Biomicroscopy 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 Screening through Week 10
Primary Safety as Assessed by Intraocular Pressure Change in baseline in intraocular pressure using the Goldmann tonometry Screening through Week 10
Primary Safety as Assessed by Dilated Fundus Examination Change from baseline in observed anomalies of the peripheral retina, macula, choroid, optic nerve and vitreous (cup/disc ratio) Screening through Week 10
Primary Safety as Assessed by Best-Corrected Distance Visual Acuity Change from baseline using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart Screening through Week 10
Secondary Efficacy as Assessed by Corneal Healing Time to corneal healing based on assessments by the Central Reading Center Week 1 through Week 10
Secondary Efficacy as Assessed by Corneal Healing at Week 4 Proportion of subjects achieving corneal healing at Week 4 assessed by the Central Reading Center Week 1 through Week 4
Secondary Efficacy as Assessed by Corneal Healing at Week 4 and Week 8 Sustained for Two Weeks Proportion of subjects achieving corneal healing at Week 4 and Week sustained for 2 weeks as assessed by the investigator Weeks 4 and 8 through Week 10
Secondary Efficacy as Assessed by Decrease in Lesion Size Time to =20% decrease in lesion size (maximum diameter) from baseline assessed by the Central Reading Center Week 1 through Week 10
Secondary Efficacy as Assessed by Time to Corneal Healing Time to corneal healing based on assessments by the investigator Week 1 through Week 10
Secondary Efficacy as Assessed by Best Corrected Distance Visual Acuity Proportion of subjects achieving a =15-letter gain in the study eye from baseline in Best Corrected Distance Visual Acuity Week 1 through Weeks 4 and 8
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