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

Zhaoke Ophthalmology

Status and phase: Completed; Phase 2

Conditions: Corneal Epithelium Defect

Treatments: Drug: Medium-dose ZKY001 eye drops; Drug: placebo; Drug: lowe-dose ZKY001 eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT06209203

ZKO-SFT-202112-TPRK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

lowe-dose ZKY001 eye drops

Experimental group

Description:

The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6

Treatment:

Drug: lowe-dose ZKY001 eye drops

Medium-dose ZKY001 eye drops

Experimental group

Description:

The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6

Treatment:

Drug: Medium-dose ZKY001 eye drops

placebo

Placebo Comparator group

Description:

The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6

Treatment:

Drug: placebo