Actively Recruiting
A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis
Led by Krystal Biotech, Inc. · Updated on 2026-02-27
60
Participants Needed
9
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. This is a Phase 1/2, multicenter, double-masked, placebo-controlled study to evaluate the safety, tolerability, and preliminary efficacy of KB801 in these subjects.
CONDITIONS
Official Title
A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have signed informed consent and agree to follow study procedures
- Age 18 years or older at consent
- Diagnosed with Stage 2 or 3 neurotrophic keratitis
- Persistent corneal epithelial defect (PCED) present without improvement between screenings
- PCED must have at least 1 mm linear measurement at first screening
- Negative pregnancy test at first screening and Day 1 for women who can become pregnant
You will not qualify if you...
- Active ocular infection or inflammation unrelated to neurotrophic keratitis in the study eye
- Use or planned use of prohibited eye treatments during study treatment period
- Expected use of therapeutic contact lenses during study treatment period
- Corneal ulcer involving the back third of the cornea, corneal melting, descemetocele, or risk of perforation at screening
- PCED larger than 8 mm linear measurement at screenings
- PCED in the central 3 mm of both corneas at screenings
- Need for punctal occlusion during treatment period
- Any eye or body condition that could affect treatment effectiveness or study participation
- Participation in another clinical trial or investigational treatment within 30 days or 5 half-lives before Day 1
- Eye surgery on study eye within 6 months before screening, except if surgery caused neurotrophic keratitis
- Corneal transplant on study eye within past 2 years or multiple past transplants
- Pregnant or nursing women
- Unwillingness to follow contraception requirements if applicable
- Known or likely noncompliance with study protocol as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
UC Irvine Alpha Clinic
Irvine, California, United States, 92617
Not Yet Recruiting
2
Azul Vision - California Eye Specialists Medical Group Inc.
Pasadena, California, United States, 91107
Actively Recruiting
3
Midwest Cornea Associates
Carmel, Indiana, United States, 46290
Actively Recruiting
4
Vance Thompson Vision
Alexandria, Minnesota, United States, 56308
Actively Recruiting
5
Minnesota Eye Consultants
Minnetonka, Minnesota, United States, 55305
Actively Recruiting
6
St. Louis Eye Institute
Town and Country, Missouri, United States, 63017
Actively Recruiting
7
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, United States, 07650
Actively Recruiting
8
Vance Thompson Vision
West Fargo, North Dakota, United States, 58078
Actively Recruiting
9
UPMC Vision Institute
Pittsburgh, Pennsylvania, United States, 15219
Not Yet Recruiting
Research Team
D
David Sweet, MD, PhD
CONTACT
B
Brittani Agostini, RN, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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