ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects in a Phase Ⅱ Clinical Trial

Phase 2

Completed

• Conditions: Corneal Epithelial Defect
• Interventions: Drug: lowe-dose ZKY001 eye drops; Drug: Medium-dose ZKY001 eye drops; Drug: ZKY001 simulated eye drops

• Registration Number: NCT06213727
• Lead Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

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 group) and a placebo control group, with 60 subjects in each group.

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 (the day of operation) to D5, and the observation period was D10±2.

Statistical analyses were performed with the use of SAS software (version 9.4 or higher) without special instructions. All statistical tests were two-sided, with a significance level of 0.05. Enrollment analysis: the number of enrolled and completed cases in each center was summarized, and the list of dropped cases was made. Overall dropout rates in each group and dropout rates related to adverse events were compared between groups with the use of the chi-square test or Fisher's exact test.

Study Timeline

• Study Start: 2022-03-15
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Age of 18-70 years old, both sexes;
2. 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;
3. 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 Criteria

1. secondary pterygium, recurrent pterygium, pseudopterygium, bilateral pterygium or conjunctival tumor;
2. Schirmer test I (topical anesthesia) ≤3mm/5min;
3. 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;
4. patients with syphilis, Sjogren's syndrome, cicatricial pemphigoid and other systemic diseases that seriously affect ocular surface structure or function;
5. rheumatoid arthritis, Sjogren syndrome, systemic lupus erythematosus, AIDS and other autoimmune diseases;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial drug group 1	lowe-dose ZKY001 eye drops	lowe-dose ZKY001 eye drops
Trial drug group 2	Medium-dose ZKY001 eye drops	Medium-dose ZKY001 eye drops
control group	ZKY001 simulated eye drops	ZKY001 simulated eye drops

Primary Outcome Measures

Name	Time	Method
Corneal epithelial defect repair area	3 days	Percentage improvement of corneal epithelial defect area from baseline in the afternoon of D3

Secondary Outcome Measures

Name	Time	Method
VAS score	5 days	the mean change of VAS scores from baseline in D3 and D5
Best Corrected Visual acuity (BCVA)	5 days	The mean change of best corrected visual acuity at D1, D3, and D5 from baseline

Trial Locations

Locations (1)

Eye Hospital of Shandong First Medical University (Shandong Eye Hospital); 🇨🇳 Jinan, Shandong, China