Actively Recruiting
A Phase 1/2, Multicenter, Double-Masked, Placebo-Controlled Study of KB801 in Subjects With Stage 2 or 3 Neurotrophic Keratitis
Led by Krystal Biotech, Inc. · Updated on 2026-02-27
60
Participants Needed
9
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KB801, a special virus-based treatment designed to deliver human nerve growth factor to the corneas of people with Stage 2 or 3 neurotrophic keratitis, a condition that affects corneal healing. This Phase 1/2 study is designed to assess the safety, tolerability, and early signs of effectiveness of KB801 compared to a placebo. The study is double-masked and placebo-controlled, involving participants with persistent corneal epithelial defects that have not improved. Participants will be randomly assigned to receive either KB801 or a placebo, applied topically to the affected eye once daily for 8 weeks. After completing treatment, they will return for a follow-up visit two weeks later to check on safety and the stability of corneal healing. Further safety monitoring will take place every three months for about one year while participants remain in the study. Throughout the trial, participants will undergo regular assessments to monitor safety, including tracking any adverse events. Researchers will evaluate healing of the corneal defects using specific measurements over 8 to 10 weeks. Safety follow-up visits extend through approximately one year to observe the durability of treatment effects and overall tolerability. Participants can expect regular visits for examinations and safety monitoring during this time.
CONDITIONS
Brief 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...
- The participant must have signed informed consent and be willing to follow study instructions.
- Aged 18 years or older at the time of consent.
- Diagnosed with Stage 2 or Stage 3 neurotrophic keratitis.
- Have a persistent corneal epithelial defect (PCED) without improvement.
- The PCED must be at least 1 mm in linear size at screening.
- Negative pregnancy test for women of child-bearing potential at screening and Day 1.
You will not qualify if you...
- Active eye infection or inflammation unrelated to neurotrophic keratitis.
- Use or anticipated need for prohibited topical treatments other than study products.
- Planned use of therapeutic contact lenses during the treatment period.
- Corneal ulcer involving the posterior third of the stroma or severe corneal damage.
- PCED larger than 8 mm at screening.
- PCED present in the central 3 mm area of both corneas.
- Anticipated need for punctal occlusion during treatment.
- Any ocular or systemic condition interfering with treatment or study participation.
- Participation in another clinical trial with investigational agents within 30 days or 5 half-lives.
- Eye surgery within 6 months before screening, unless causing neurotrophic keratitis.
- Corneal transplantation on the study eye within 2 years or multiple transplant history.
- Pregnancy or nursing.
- Unwillingness to comply with contraception requirements if applicable.
- Known or suspected noncompliance with study protocol per investigator judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive KB801 or placebo as a topical eye treatment daily for 8 weeks.
Weekly visits during treatment
Duration - Approximately 1 year after treatment
Participants return for a follow-up visit 2 weeks after treatment to monitor safety and corneal healing, then continue safety follow-up visits every 3 months for approximately 1 year.
1 visit 2 weeks after treatment and quarterly visits for safety monitoring
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
B
Brittani Agostini, RN, CCRC
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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