Status:
COMPLETED
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops
Lead Sponsor:
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Conditions:
Corneal Epithelium Defect
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
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,Med...
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 tes...
Eligibility Criteria
Inclusion
- Age of 18-40 years old, regardless of gender;
- 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;
- Schirmer test I ≥10mm/5min;
Exclusion
- prior corneal refractive surgery or keratoplasty;
- 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.);
- incomplete eyelid closure;
- corneal degeneration, corneal stroma or endothelial damage or malnutrition;
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06209203
Start Date
August 3 2022
End Date
November 8 2022
Last Update
January 15 2025
Active Locations (1)
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1
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China