Corneal DefectPhase 2NCT04228926
Evaluating the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects
A Phase 2 study testing ZKY001 eye drops 0.3g:0.006mg, ZKY001 eye drops 0.3g:0.012mg and ZKY001 simulated eye drops in people with Corneal Defect, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Defect
- What is being tested?
- ZKY001 eye drops 0.3g:0.006mg, ZKY001 eye drops 0.3g:0.012mg and ZKY001 simulated eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye ＆ Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, 200030
Yan Wang, PHD, 021-64377134
About this study
Official title: 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
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.
Read the detailed description
This study is an exploratory phase II clinical study with no sample size estimation.According to the results of the preliminary animal experiments and phase I clinical trials, 2 concentrations (0.002% and 0.004%ZKY001eye drops) were selected as the experimental group, and 1 placebo control group was selected, with 35 subjects in each group and a total of 105 subjects.Each subject will drop the study drug into the test eye (the surgical eye is taken as the test eye) according to the randomly assigned drug number.
- Conditions
- Corneal Defect
- Being tested
- ZKY001 eye drops 0.3g:0.006mg, ZKY001 eye drops 0.3g:0.012mg, ZKY001 simulated eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZKY001 eye drops 0.3g:0.006mgDrug
Also called shengfatai-eye drops, the Germinal Peptide eye drops
ZKY001 eye drops of 0.002% continuously for up to 14±2 days after Corneal endothelial transplantation
ZKY001 eye drops 0.3g:0.012mgDrug
Also called shengfatai-eye drops, the Germinal Peptide eye drops
ZKY001 eye drops of 0.004% continuously for up to 14±2 days after Corneal endothelial transplantation
ZKY001 simulated eye dropsDrug
Also called the placebo
ZKY001 simulated eye drops continuously for up to 14±2 days after Corneal endothelial transplantation
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: ZKY001 simulated eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 3, 8:00 am±1hour
Secondary outcomes (5)
The subject's symptoms and signs will be evaluated on the General Arbitroid
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
Measured: Day 3, Day6 、Day15 8:00 am±1hour
Scoring with D6 and D15 corneal fluorescein staining
Subjects underwent corneal fluorescein staining and scoring before the first dose of Day1, Day6 and Day15
Measured: 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
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%
Measured: 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
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
Measured: Day 2、Day4、Day5 8:00 am±1hour
The incidence of reexfoliation of corneal epithelium was observed
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
Measured: Day 3, Day4，Day5，Day6，Day15±2 8:00 am±1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start24 Dec 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiuli Zhao, PHD, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228926
- Sponsor's protocol ID
- ZK-SFT-2019
- Status last verified
- Sep 2021
- First submitted
- 1 Jan 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04228926
- Acronym / sponsor ID
- ZK-SFT-2019
- Conditions
- Corneal Defect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is an exploratory phase II clinical study with no sample size estimation.According to the results of the preliminary animal experiments and phase I clinical trials, 2 concentrations (0.002% and 0.004%ZKY001eye drops) were selected as the experimental group, and 1 placebo control group was selected, with 35 subjects in each group and a total of 105 subjects.Each subject will drop the study drug into the test eye (the surgical eye is taken as the test eye) according to the randomly assigned drug number.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.002% ZKY001 eye drops | Experimental | Drug: ZKY001 eye drops 0.3g:0.006mgExperimental 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). |
| 0.004% ZKY001 eye drops | Experimental | Drug: ZKY001 eye drops 0.3g:0.012mgExperimental 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). |
| The placebo | Placebo comparator | Drug: ZKY001 simulated eye dropsPlacebo 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZKY001 eye drops 0.3g:0.006mgAlso: shengfatai-eye drops, the Germinal Peptide eye dropsZKY001 eye drops of 0.002% continuously for up to 14±2 days after Corneal endothelial transplantation | Drug | 0.002% ZKY001 eye drops |
| ZKY001 eye drops 0.3g:0.012mgAlso: shengfatai-eye drops, the Germinal Peptide eye dropsZKY001 eye drops of 0.004% continuously for up to 14±2 days after Corneal endothelial transplantation | Drug | 0.004% ZKY001 eye drops |
| ZKY001 simulated eye dropsAlso: the placeboZKY001 simulated eye drops continuously for up to 14±2 days after Corneal endothelial transplantation | Drug | The placebo |
Primary outcome
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
5 secondary outcomes
The subject's symptoms and signs will be evaluated on the General Arbitroid
Time frame: Day 3, Day6 、Day15 8:00 am±1hour
Scoring with D6 and D15 corneal fluorescein staining
Time frame: 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
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
The incidence of reexfoliation of corneal epithelium was observed
Time frame: Day 3, Day4，Day5，Day6，Day15±2 8:00 am±1hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Zhao, PHD study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZKY001 eye drops 0.3g:0.006mg, ZKY001 eye drops 0.3g:0.012mg and ZKY001 simulated eye drops in people with Corneal Defect, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zhao, PHD (010-58268486 ext. 8008, xiulizhao@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.