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

NCT06213727 | Completed Phase 2

• 1 other identifier: ZKO-SFT-202106-PTY
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Epithelial Defect

Outcome Measures

Primary Outcomes (1)

• Corneal epithelial defect repair area

  Percentage improvement of corneal epithelial defect area from baseline in the afternoon of D3

  3 days

Secondary Outcomes (2)

• VAS score

  5 days

• Best Corrected Visual acuity (BCVA)

  5 days

Study Arms (3)

Trial drug group 1

EXPERIMENTAL

lowe-dose ZKY001 eye drops

Drug: lowe-dose ZKY001 eye drops

Trial drug group 2

EXPERIMENTAL

Medium-dose ZKY001 eye drops

Drug: Medium-dose ZKY001 eye drops

control group

PLACEBO COMPARATOR

ZKY001 simulated eye drops

Drug: ZKY001 simulated eye drops

Interventions

lowe-dose ZKY001 eye drops DRUG

eye drops

Trial drug group 1

Medium-dose ZKY001 eye drops DRUG

eye drops

Trial drug group 2

ZKY001 simulated eye drops DRUG

eye drops

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Eye Hospital of Shandong First Medical University (Shandong Eye Hospital)

Jinan, Shandong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: March 15, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)