ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects in a Phase Ⅱ Clinical Trial (NCT06213727) | Clinical Trial Compass
CompletedPhase 2
ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects in a Phase Ⅱ Clinical Trial
China180 participantsStarted 2022-03-15
Plain-language summary
A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. The study included two experimental groups (low-dose ZKY001 eye drops group and medium-dose ZKY001 eye drops group) and a placebo control group, with 60 subjects in each group.
Who can participate
Age range
18 Years – 70 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
. Age of 18-70 years old, both sexes;
. patients were diagnosed as primary pterygium with nasal onset, and the head tip of pterygium invaded the cornea ≥3mm and ≤5mm, and underwent pterygium excision combined with conjunctival autotransplantation with autologous limbal stem cells;
. Except for the pterygium neck under the slit lamp during the screening period, the limbal anatomy was normal without obvious abnormalities (e.g., scar, neovascularization that had invaded the cornea, or pseudopterygium);
. severe blepharitis and/or severe meibomian gland disease, recurrent corneal erosion, chronic corneal disease, chemical burn and other ocular diseases that seriously affect ocular surface structure or function;
. patients with syphilis, Sjogren's syndrome, cicatricial pemphigoid and other systemic diseases that seriously affect ocular surface structure or function;
. rheumatoid arthritis, Sjogren syndrome, systemic lupus erythematosus, AIDS and other autoimmune diseases;
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.