Corneal Epithelium DefectPhase 2TPRKNCT06209203
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops
A Phase 2 study testing lowe-dose ZKY001 eye drops and Medium-dose ZKY001 eye drops in people with Corneal Epithelium Defect, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Corneal Epithelium Defect
- What is being tested?
- lowe-dose ZKY001 eye drops and Medium-dose ZKY001 eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2022to 8 Nov 2022
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: 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
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.
Read the 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 tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified.
- Conditions
- Corneal Epithelium Defect
- Being tested
- lowe-dose ZKY001 eye drops, Medium-dose ZKY001 eye drops, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lowe-dose ZKY001 eye dropsDrug
Also called ZKY001
eye drops
Medium-dose ZKY001 eye dropsDrug
Also called ZKY001
eye drops
placeboDrug
Also called Simulated eye drops
eye drops
| Study group | Role | What they receive |
|---|---|---|
| lowe-dose ZKY001 eye drops | Experimental | The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6 Receives: Drug: lowe-dose ZKY001 eye drops |
| Medium-dose ZKY001 eye drops | Experimental | The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6 Receives: Drug: Medium-dose ZKY001 eye drops |
| placebo | Placebo comparator | The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing time
Corneal epithelial healing time
Measured: seven days
Secondary outcomes (1)
number of healing
The percentage of corneal healing at 24h, 48h, 72h, 120h and 168h after operation
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start3 Aug 2022
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Epithelium 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xingtao Zhou, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209203
- Sponsor's protocol ID
- ZKO-SFT-202112-TPRK
- Acronym
- TPRK
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. 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 Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops in Patients with Corneal Epithelial Defects After TPRK
- ClinicalTrials.gov ID
- NCT06209203
- Acronym / sponsor ID
- TPRK / ZKO-SFT-202112-TPRK
- Conditions
- Corneal Epithelium Defect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 17 Jan 2024 (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.
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.
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 tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lowe-dose ZKY001 eye drops | Experimental | Drug: lowe-dose ZKY001 eye dropsThe 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 | Experimental | Drug: Medium-dose ZKY001 eye dropsThe drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6 |
| placebo | Placebo comparator | Drug: placeboThe drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
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 |
|---|---|---|
| lowe-dose ZKY001 eye dropsAlso: ZKY001eye drops | Drug | lowe-dose ZKY001 eye drops |
| Medium-dose ZKY001 eye dropsAlso: ZKY001eye drops | Drug | Medium-dose ZKY001 eye drops |
| placeboAlso: Simulated eye dropseye drops | Drug | placebo |
Primary outcome
healing time
Time frame: seven days
Corneal epithelial healing time
1 secondary outcome
number of healing
Time frame: seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
Related trials for Corneal Epithelium Defect
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Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK
Corneal Epithelial Wound Healing
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.
Xingtao Zhou principal investigator
Eye & ENT Hospital of Fudan University
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 lowe-dose ZKY001 eye drops and Medium-dose ZKY001 eye drops in people with Corneal Epithelium 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing time (time frame: seven days). 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 15 Jan 2025.