A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops
TPRK
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2022
CompletedFirst Submitted
Initial submission to the registry
January 6, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedJanuary 15, 2025
January 1, 2024
3 months
January 6, 2024
January 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
healing time
Corneal epithelial healing time
seven days
Secondary Outcomes (1)
number of healing
seven days
Other Outcomes (1)
Corneal staining
seven days
Study Arms (3)
lowe-dose ZKY001 eye drops
EXPERIMENTALThe 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
EXPERIMENTALThe drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6
placebo
PLACEBO COMPARATORThe drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Study Officials
- PRINCIPAL INVESTIGATOR
Xingtao Zhou
Eye & ENT Hospital of Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2024
First Posted
January 17, 2024
Study Start
August 3, 2022
Primary Completion
November 8, 2022
Study Completion
November 8, 2022
Last Updated
January 15, 2025
Record last verified: 2024-01