Evaluating the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects

NCT04228926 | Unknown Phase 2

• 1 other identifier: ZK-SFT-2019
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The subjects of this study were patients who underwent corneal endothelial transplantation,who were randomly divided into 3 groups, 2 groups (0.002% and 0.004% ZKY001 eye drops) and 1 placebo control group.

Conditions

Corneal Defect

Outcome Measures

Primary Outcomes (1)

• The change of corneal epithelial defect area on Day 3 compared with that on baseline will be calculated by the grid method

  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 Outcomes (5)

• The subject's symptoms and signs will be evaluated on the General Arbitroid

  Day 3, Day6 、Day15 8:00 am±1hour

• Scoring with D6 and D15 corneal fluorescein staining

  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

  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

  Day 2、Day4、Day5 8:00 am±1hour

• The incidence of reexfoliation of corneal epithelium was observed

  Day 3, Day4，Day5，Day6，Day15±2 8:00 am±1hour

Study Arms (3)

0.002% ZKY001 eye drops

EXPERIMENTAL

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).

Drug: ZKY001 eye drops 0.3g:0.006mg

0.004% ZKY001 eye drops

EXPERIMENTAL

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).

Drug: ZKY001 eye drops 0.3g:0.012mg

The placebo

PLACEBO COMPARATOR

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).

Drug: ZKY001 simulated eye drops

Interventions

ZKY001 eye drops 0.3g:0.006mg DRUG

ZKY001 eye drops of 0.002% continuously for up to 14±2 days after Corneal endothelial transplantation

Also known as: shengfatai-eye drops, the Germinal Peptide eye drops

0.002% ZKY001 eye drops

ZKY001 eye drops 0.3g:0.012mg DRUG

ZKY001 eye drops of 0.004% continuously for up to 14±2 days after Corneal endothelial transplantation

Also known as: shengfatai-eye drops, the Germinal Peptide eye drops

0.004% ZKY001 eye drops

ZKY001 simulated eye drops DRUG

ZKY001 simulated eye drops continuously for up to 14±2 days after Corneal endothelial transplantation

Also known as: the placebo

The placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Eye ＆ Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Study Officials

• Xiuli Zhao, PHD

  Beijing Tongren Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiuli Zhao, PHD

CONTACT

010-58268486; xiulizhao@medmail.com.cn

Feng Wu, PHD

CONTACT

010-58268486; bjtrec@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 14, 2020
• Study Start: December 24, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

CN (1)