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.
- 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.
Who Can Participate?
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.
- 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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
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
Amol
Sura
Protocol Number
PRO00111355
NCT ID
NCT04909450
Phase
I/II
Enrollment Status
OPEN TO ACCRUAL