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

Corneal Epithelium Defect Clinical Trial

— TPRK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06209203
• Other study ID #: ZKO-SFT-202112-TPRK
• Status: Completed
• Phase: Phase 2
• Start date: August 3, 2022
• Est. completion date: November 8, 2022

Study information

• Verified date: January 2024
• Source: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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;

Related Conditions & MeSH terms

• Corneal Epithelium Defect

Intervention

Drug:
• lowe-dose ZKY001 eye drops
eye drops
• Medium-dose ZKY001 eye drops
eye drops
• placebo
eye drops

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Corneal staining	The percentage of corneal staining negative at 48h, 72h, 120h and 168h after surgery	seven days
Primary	healing time	Corneal epithelial healing time	seven days
Secondary	number of healing	The percentage of corneal healing at 24h, 48h, 72h, 120h and 168h after operation	seven days