Status:
COMPLETED
ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects in a Phase Ⅱ Clinical Trial
Lead Sponsor:
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Conditions:
Corneal Epithelial Defect
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 gr...
Detailed Description
Each subject had the study drug instilled into the study eye according to the randomly obtained drug number. Duration OF THE STUDY：The screening period was D-5 to D-1, the experimental period was D0 ...
Eligibility Criteria
Inclusion
- 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);
Exclusion
- secondary pterygium, recurrent pterygium, pseudopterygium, bilateral pterygium or conjunctival tumor;
- Schirmer test I (topical anesthesia) ≤3mm/5min;
- 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;
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06213727
Start Date
March 15 2022
End Date
November 14 2022
Last Update
January 19 2024
Active Locations (1)
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1
Eye Hospital of Shandong First Medical University (Shandong Eye Hospital)
Jinan, Shandong, China