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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-03

Study Completion Date

2022-11-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Corneal Epithelium Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

lowe-dose ZKY001 eye drops

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Medium-dose ZKY001 eye drops

Intervention Type DRUG

eye drops

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

eye drops

Interventions

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lowe-dose ZKY001 eye drops

eye drops

Intervention Type DRUG

Medium-dose ZKY001 eye drops

eye drops

Intervention Type DRUG

placebo

eye drops

Intervention Type DRUG

Other Intervention Names

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ZKY001 ZKY001 Simulated eye drops

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No