CSB-C20-003 (Neurotrophic Keratitis) - Clinical Trial

What is the Purpose of this Study?


If you choose to join this study, you will:
- Be randomly assigned (like a coin flip) to 1 of 2 groups
-- One group will get the study drops
-- The other group will get a placebo (eye drops with no active medicine)

This study is blinded, so you will not know to which group you have been assigned. If you are assigned to receive the placebo, we will let you know at the end of the initial study period and you will have the option to receive the study drops if you want.

Depending on the eye drops you will receive, you will:
- Keep in touch with the study team between 2.5 and 5 months
- Visit our clinic at the Duke Eye Center between 10 and 20 times

At various visits, you will have blood draws, answer questionnaires, and have eye exams and vision tests.

What is the Condition Being Studied?

Stage 2 and 3 Neurotrophic Keratitis

Who Can Participate in the Study?

Key Eligibility

Adults ages 18+ who:
- Are diagnosed with stage 2 or stage 3 neurotrophic keratitis
- Do not have an eye infection or inflammation

For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.

Age Group

What is Involved?


We are doing this study to find out if an investigational type of eye drop, called CSB-001 ophthalmic solution 0.1% (the study drops), is a safe an effective treatment for stage 2 and 3 neurotrophic keratitis.

Study Details

Full Title
CSB-001 Ophthalmic Solution 0.1% 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
Principal Investigator
Protocol Number
IRB: PRO00111355
NCT: NCT04909450
Phase I/II
Enrollment Status
Open for Enrollment