A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops (TPRK)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops in Patients With Corneal Epithelial Defects After TPRK

A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects in each group.

Study Overview

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

Detailed Description

Study cycle: 7 days screening period (d-7-D-1), 7 days treatment period (D0-D6), and the end of the study on D7.

Statistical analysis was performed using SAS9.4 or above software. All statistical tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Eye & ENT Hospital of Fudan University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age of 18-40 years old, regardless of gender;
2. Plan TPRK for myopia and/or myopic astigmatism, meet the indications for TPRK, and set the ablation diameter of the optical zone at 6.0-6.5 mm;
3. Schirmer test I ≥10mm/5min;

Exclusion Criteria:

1. prior corneal refractive surgery or keratoplasty;
2. Contraindications to TPRK surgery, including severe ocular surface disease that may affect the corneal epithelium, active ocular inflammation, moderate to severe dry eye, keratoconus or other types of corneal ectasia, thin corneas, severe lesions of ocular appendages (such as eyelid defects, deformations, etc.), glaucoma, cataract that affects vision, History of systemic immune diseases (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.);
3. incomplete eyelid closure;
4. corneal degeneration, corneal stroma or endothelial damage or malnutrition;

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: lowe-dose ZKY001 eye drops; The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6	Drug: lowe-dose ZKY001 eye drops; eye drops; Other Names: ZKY001
Experimental: Medium-dose ZKY001 eye drops; The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6	Drug: Medium-dose ZKY001 eye drops; eye drops; Other Names: ZKY001
Placebo Comparator: placebo; The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6	Drug: placebo; eye drops; Other Names: Simulated eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing time	Corneal epithelial healing time	seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of healing	The percentage of corneal healing at 24h, 48h, 72h, 120h and 168h after operation	seven days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal staining	The percentage of corneal staining negative at 48h, 72h, 120h and 168h after surgery	seven days

Collaborators and Investigators

• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Investigators: Principal Investigator: Xingtao Zhou, Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: January 6, 2024
• First Submitted That Met QC Criteria: January 6, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 6, 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-202112-TPRK

Drug and device information, study documents

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