To Evaluate the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial De… (NCT07120308) | Clinical Trial Compass
CompletedPhase 2
To Evaluate the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects Caused by Neurotrophic Keratitis
China28 participantsStarted 2021-09-15
Plain-language summary
An investigator-initiated single-center, randomized, double-blind, placebo-controlled clinical study .The main purpose is to evaluate the effectiveness of ZKY001 eye drops in treating corneal epithelial defects caused by neurotrophic keratitis in patients.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years ≤ aged ≤ 80 years; Consistent with the diagnosis of neurotrophic keratitis caused by diabetes or the herpes simplex virus; Patients with Stage 2 or Stage 3 neurotrophic keratitis,involving only one eye; PED or corneal ulceration of at least 2 weeks' duration refractory to one or more conventional non-surgical treatments for neurotrophic keratitis (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; medications that can decrease corneal sensitivity; therapeutic contact lenses and Cenegermin eye drops); Signed informed consent forms。
Exclusion Criteria:
* Patients with Stage 2 or 3 NK affecting both eyes; Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK in the affected eye; Any other ocular disease requiring topical ocular treatment in the affected eye during the study treatment period; Patients with severe vision loss in the affected eye with no potential for visual improvement in the opinion of the Investigator because of the study treatment; Schirmer's test without anesthesia ≤ 3 mm/ 5 minutes in the affected eye; Patients with severe blepharitis and/or severe meibomian gland disease in the affected eye; History of laser surgical procedures in the affected eye within the 3 months before study enrollment,history of any ocular surgery (except retinal laser photocoagulation) in the affected eye within the 1 month before study …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects with corneal epithelial healing(<0.5 mm lesion size) at D57.