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

To Evaluate the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects in a Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅱ Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Corneal Epithelial Defect
• Intervention / Treatment: Drug: lowe-dose ZKY001 eye drops; Drug: Medium-dose ZKY001 eye drops; Drug: ZKY001 simulated eye drops

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Eye Hospital of Shandong First Medical University (Shandong Eye Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trial drug group 1; lowe-dose ZKY001 eye drops	Drug: lowe-dose ZKY001 eye drops; eye drops
Experimental: Trial drug group 2; Medium-dose ZKY001 eye drops	Drug: Medium-dose ZKY001 eye drops; eye drops
Placebo Comparator: control group; ZKY001 simulated eye drops	Drug: ZKY001 simulated eye drops; eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal epithelial defect repair area	Percentage improvement of corneal epithelial defect area from baseline in the afternoon of D3	3 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: ZKO-SFT-202106-PTY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No