- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228926
Evaluating the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of ZKY001 Eye Drops in Patients With Corneal Epithelial Defects After Corneal Endothelial Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xiuli Zhao, PHD
- Phone Number: 8008 010-58268486
- Email: xiulizhao@medmail.com.cn
Study Contact Backup
- Name: Feng Wu, PHD
- Phone Number: 8008 010-58268486
- Email: bjtrec@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Recruiting
- Eye & ENT Hospital of Fudan University
-
Contact:
- Yan Wang, PHD
- Phone Number: 021-64377134
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18-80, regardless of gender;
- patients who have undergone DSAEK or DMEK and need to remove corneal epithelium;
- Schirmer test I ≥10mm/5min;
- normal corneal limbus structure under slit lamp during screening period;
- sign the informed consent.
Exclusion Criteria:
- intraocular pressure > 21mmHg or baseline intraocular pressure > 35mmHg during screening period;
- fasting blood glucose > 9.0mmol/L during screening period;
- postoperative complications occurred, such as dislocation of the implant and high intraocular pressure caused by air bubbles in the anterior chamber;
- suffered from eye infection, optic neuritis, pigment membrane inflammation, or fundus, macular lesions that affect vision, glaucoma;
- serious cardiovascular history (congestive heart failure, uncontrolled hypertension, unstable coronary heart disease or myocardial infarction or severe arrhythmia, etc.);
- severe hepatic and renal insufficiency, alanine aminotransferase (ALT), alanine aminotransferase (AST) ≥ 2 times the normal upper limit, blood creatinine (Cr) ≥ 1.5 times the normal upper limit;
- those who wear contact lenses within 3 days before screening;
- screening drugs that have used corneal repair effect within the first 3 days;
- have received corneal refractive surgery or keratoplasty;
- have received internal eye surgery within 3 months before screening or need to undergo internal eye surgery during the study period;
- have participated in other clinical trials or are participating in other clinical trials within 3 months prior to screening;
- suffering from central nervous system disease and/or mental state inability to cooperate;
- women in pregnancy, lactation or childbearing age do not take effective contraceptive measures;
- allergy to the test product and basic drugs;
- patients who are not considered appropriate to participate in this study, including those who are unable or unwilling to comply with the protocol requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.002% ZKY001 eye drops
Experimental group A: 35 subjects .0.002% ZKY001 eye drops .
4 times a day,1 drop every time, continuously administered for 14±2 days ZKY001 eye drops will be directly dripped into the test eye (the surgical eye was taken as the test eye).
|
ZKY001 eye drops of 0.002% continuously for up to 14±2 days after Corneal endothelial transplantation
Other Names:
|
Experimental: 0.004% ZKY001 eye drops
Experimental group B: 35 subjects .0.004% ZKY001 eye drops .
4 times a day,1 drop every time, continuously administered for 14±2 days ZKY001 eye drops will be directly dripped into the test eye (the surgical eye was taken as the test eye).
|
ZKY001 eye drops of 0.004% continuously for up to 14±2 days after Corneal endothelial transplantation
Other Names:
|
Placebo Comparator: The placebo
Placebo group C: ZKY001 simulated eye drops .4
times a day,1 drop every time, continuously administered for 14±2 days ZKY001 simulated eye drops will be directly dripped into the test eye (the surgical eye was taken as the test eye).
|
ZKY001 simulated eye drops continuously for up to 14±2 days after Corneal endothelial transplantation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of corneal epithelial defect area on Day 3 compared with that on baseline will be calculated by the grid method
Time Frame: Day 3, 8:00 am±1hour
|
Subjects will undergo fluorescein staining of the cornea, slit-lamp examination and photography (8:00 ±1h) before first administration on Day1(the first day after surgery,baseline),Day3 (the third day after surgery).After slit-lamp photography was scanned by the scanner, image pro plus software was used to scale the photo to the same size as the test eye, and then the grid method was used to calculate the area of the corneal defect in the photo. Improvement in epithelial defect area = defect area on baseline - defect area on Day3 |
Day 3, 8:00 am±1hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The subject's symptoms and signs will be evaluated on the General Arbitroid
Time Frame: Day 3, Day6 、Day15 8:00 am±1hour
|
Subjects' symptoms and signs were evaluated on the general symptom and signs scale at Day1 before fluorescein staining of the cornea. The mean change of the total score of symptoms and signs on Day 3、Day6 、Day15 after the operation compared with the baseline |
Day 3, Day6 、Day15 8:00 am±1hour
|
Scoring with D6 and D15 corneal fluorescein staining
Time Frame: Day6 、Day15 8:00 am±1hour
|
Subjects underwent corneal fluorescein staining and scoring before the first dose of Day1, Day6 and Day15
|
Day6 、Day15 8:00 am±1hour
|
The improvement rate of corneal epithelial defect area on Day 3 postoperation after surgery compared with that at baseline (Day1 postoperation ) will be calculated by the grid method
Time Frame: Day 3, 8:00 am±1hour
|
Subjects will undergo fluorescein staining of the cornea, slit-lamp examination and photography (8:00 ±1h) before first administration on Day1(the first day after surgery,baseline),Day3 (the third day after surgery).After slit-lamp photography was scanned by the scanner, image pro plus software was used to scale the photo to the same size as the test eye, and then the grid method was used to calculate the area of the corneal defect in the photo. Improvement rate of corneal epithelial defect area=( defect area at baseline - defect area at Day3)/defect area at baseline ✖100% |
Day 3, 8:00 am±1hour
|
The change of corneal epithelial defect area on Day 2、Day4、Day5 compared with that on baseline(Day 1) will be calculated by the grid method
Time Frame: Day 2、Day4、Day5 8:00 am±1hour
|
Subjects will undergo fluorescein staining of the cornea, slit-lamp examination and photography (8:00 ±1h) before first administration on Day1,Day 2、Day4、Day5.After slit-lamp photography was scanned by the scanner, image pro plus software was used to scale the photo to the same size as the test eye, and then the grid method was used to calculate the area of the corneal defect in the photo. Day2 Improvement in epithelial defect area = defect area on baseline - defect area on Day2 Day4Improvement in epithelial defect area = defect area on baseline - defect area on Day4 Day5 Improvement in epithelial defect area = defect area on baseline - defect area on Day5 |
Day 2、Day4、Day5 8:00 am±1hour
|
The incidence of reexfoliation of corneal epithelium was observed
Time Frame: Day 3, Day4,Day5,Day6,Day15±2 8:00 am±1hour
|
incidence of re-exfoliation of corneal epithelium on Day3、Day4、Day5、Day6、Day15±2 In the process of corneal epithelium repair, the epithelium may reexfoliate after covering the wound.Reexfoliation of the corneal epithelium was defined as positive corneal fluorescein staining under slit lamp microscope,Corneal fluorescein staining was performed before the first administration
|
Day 3, Day4,Day5,Day6,Day15±2 8:00 am±1hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZK-SFT-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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