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

Phase 2

Completed

• Conditions: Corneal Epithelium Defect
• Interventions: Drug: lowe-dose ZKY001 eye drops; Drug: Medium-dose ZKY001 eye drops; Drug: placebo

• Registration Number: NCT06209203
• Lead Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Brief Summary

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.

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 Timeline

• Study Start: 2022-08-03
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Status Verified: 2024-01
• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-06
• Study First Posted: 2024-01-17
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lowe-dose ZKY001 eye drops	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
Medium-dose ZKY001 eye drops	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
placebo	placebo	The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6

Primary Outcome Measures

Name	Time	Method
healing time	seven days	Corneal epithelial healing time

Secondary Outcome Measures

Name	Time	Method
number of healing	seven days	The percentage of corneal healing at 24h, 48h, 72h, 120h and 168h after operation

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China