Corneal Epithelial Wound HealingCLCSNCT06840990
Cross-linked CMC and Silk Proteins in Corneal Re-epithelization
An observational study of Corneal Epithelial Wound Healing, run by D&V FARMA srl at 1 site in Italy.
Trial summary
Data analyses and revision of the corneal re-epithelization in patients who underwent either PRK (Photorefractive Keratectomy), CXL (Corneal Cross-Linking), PTK (phototherapeutic keratectomy), or experienced a corneal abrasion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Epithelial Wound Healing
- What is being tested?
- CXC-SP and CTRL
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 1 Jun 2024
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data derived from subject who undergone surgical procedures involving de-epithelialization, which included CXL, PRK, and PTK, as well as those with a first diagnosis of corneal abrasionand treated with the ophthalmic solution containing CX-CMC and SP and with lubricant eye drops will be collected and analysed.
Who may be able to join
- Patients who had undergone surgical procedures involving de-epithelialization, which included CXL, PRK, and PTK, as well as those with a first diagnosis of corneal abrasion
Who cannot join
- patients with known allergies or hypersensitivity to any components of the tested formulations or standard therapies, or those requiring different treatments compared to the rest of the study population
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ophthalmic Solution in Corneal Re-epithelization
Data analyses and revision of the corneal re-epithelization in patients who underwent either PRK (Photorefractive Keratectomy), CXL (Corneal Cross-Linking), PTK (phototherapeutic keratectomy), or experienced a corneal abrasion. A novel ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP) has been made available on the market. Both molecules have been widely studied for their wound healing properties in the ophtalmic field. This new ophthalmic solution is the first on the market formulated with a CX-CMC and SP.
- Conditions
- Corneal Epithelial Wound Healing
- Being tested
- CXC-SP, CTRL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXC-SPDevice
Standard therapy plus sterile Isotonic ophthalmic solution based on CX-CMC and silk protein, istilled six time a day until complete healing.
CTRLDevice
Standard therapy plus sterile ophtalmic isotonic solution for six time a day until complete healing.
| Study group | Role | What they receive |
|---|---|---|
| CXC-SP | subjects who underwent either PRK, CXL, PTK or experienced a corneal abrasion treated with a standard therapy plus silk protein and CX-CMC-based eye drops. Receives: Device: CXC-SP | |
| CTRL | subjects who underwent either PRK , CXL , PTK , or experienced a corneal abrasion. The subjects were treated with the standard therapy only. Receives: Device: CTRL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal re-ephitalization
To evaluate and follow the corneal re-ephitalization process a topograph measuring epithelium thickness will be used.
Measured: 2 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Jan 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Corneal Epithelial Wound HealingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- D&V FARMA srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- San Giovanni Addolorata Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840990
- Sponsor's protocol ID
- COR-WH
- Acronym
- CLCS
- Status last verified
- Sep 2024
- First submitted
- 18 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel-Naby W, Cole B, Liu A, Liu J, Wan P, Schreiner R, Infanger DW, Paulson NB, Lawrence BD, Rosenblatt MI. Treatment with solubilized Silk-Derived Protein (SDP) enhances rabbit corneal epithelial wound healing. PLoS One. 2017 Nov 20;12(11):e0188154. doi: 10.1371/journal.pone.0188154. eCollection 2017.
PubMed 29155856Garrett Q, Simmons PA, Xu S, Vehige J, Zhao Z, Ehrmann K, Willcox M. Carboxymethylcellulose binds to human corneal epithelial cells and is a modulator of corneal epithelial wound healing. Invest Ophthalmol Vis Sci. 2007 Apr;48(4):1559-67. doi: 10.1167/iovs.06-0848.
PubMed 17389485Kundu J, Mohapatra R, Kundu SC. Silk fibroin/sodium carboxymethylcellulose blended films for biotechnological applications. J Biomater Sci Polym Ed. 2011;22(4-6):519-39. doi: 10.1163/092050610X487864. Epub 2010 Jun 21.
PubMed 20566044Tran SH, Wilson CG, Seib FP. A Review of the Emerging Role of Silk for the Treatment of the Eye. Pharm Res. 2018 Nov 5;35(12):248. doi: 10.1007/s11095-018-2534-y.
PubMed 30397820Lee JS, Lee SU, Che CY, Lee JE. Comparison of cytotoxicity and wound healing effect of carboxymethylcellulose and hyaluronic acid on human corneal epithelial cells. Int J Ophthalmol. 2015 Apr 18;8(2):215-21. doi: 10.3980/j.issn.2222-3959.2015.02.01. eCollection 2015.
PubMed 25938030
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ophthalmic Solution in Corneal Re-epithelization
- ClinicalTrials.gov ID
- NCT06840990
- Acronym / sponsor ID
- CLCS / COR-WH
- Conditions
- Corneal Epithelial Wound Healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- D&V FARMA srlIndustry (pharma, biotech, devices)
- Collaborators
- San Giovanni Addolorata Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 21 Feb 2025 (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.
Data analyses and revision of the corneal re-epithelization in patients who underwent either PRK (Photorefractive Keratectomy), CXL (Corneal Cross-Linking), PTK (phototherapeutic keratectomy), or experienced a corneal abrasion. A novel ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP) has been made available on the market. Both molecules have been widely studied for their wound healing properties in the ophtalmic field. This new ophthalmic solution is the first on the market formulated with a CX-CMC and SP.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CXC-SP | – | Device: CXC-SPsubjects who underwent either PRK, CXL, PTK or experienced a corneal abrasion treated with a standard therapy plus silk protein and CX-CMC-based eye drops. |
| CTRL | – | Device: CTRLsubjects who underwent either PRK , CXL , PTK , or experienced a corneal abrasion. The subjects were treated with the standard therapy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data derived from subject who undergone surgical procedures involving de-epithelialization, which included CXL, PRK, and PTK, as well as those with a first diagnosis of corneal abrasionand treated with the ophthalmic solution containing CX-CMC and SP and with lubricant eye drops will be collected and analysed.
Key inclusion criteria (1 listed)
- Patients who had undergone surgical procedures involving de-epithelialization, which included CXL, PRK, and PTK, as well as those with a first diagnosis of corneal abrasion
Key exclusion criteria (1 listed)
- patients with known allergies or hypersensitivity to any components of the tested formulations or standard therapies, or those requiring different treatments compared to the rest of the study population
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 |
|---|---|---|
| CXC-SPStandard therapy plus sterile Isotonic ophthalmic solution based on CX-CMC and silk protein, istilled six time a day until complete healing. | Device | CXC-SP |
| CTRLStandard therapy plus sterile ophtalmic isotonic solution for six time a day until complete healing. | Device | CTRL |
Primary outcome
Corneal re-ephitalization
Time frame: 2 WEEKS
To evaluate and follow the corneal re-ephitalization process a topograph measuring epithelium thickness will be used.
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 7 Mar 2025.
- Background: PubMed 29155856Abdel-Naby W, Cole B, Liu A, Liu J, Wan P, Schreiner R, Infanger DW, Paulson NB, Lawrence BD, Rosenblatt MI. Treatment with solubilized Silk-Derived Protein (SDP) enhances rabbit corneal epithelial wound healing. PLoS One. 2017 Nov 20;12(11):e0188154. doi: 10.1371/journal.pone.0188154. eCollection 2017.
- Background: PubMed 17389485Garrett Q, Simmons PA, Xu S, Vehige J, Zhao Z, Ehrmann K, Willcox M. Carboxymethylcellulose binds to human corneal epithelial cells and is a modulator of corneal epithelial wound healing. Invest Ophthalmol Vis Sci. 2007 Apr;48(4):1559-67. doi: 10.1167/iovs.06-0848.
- Background: PubMed 20566044Kundu J, Mohapatra R, Kundu SC. Silk fibroin/sodium carboxymethylcellulose blended films for biotechnological applications. J Biomater Sci Polym Ed. 2011;22(4-6):519-39. doi: 10.1163/092050610X487864. Epub 2010 Jun 21.
- Background: PubMed 30397820Tran SH, Wilson CG, Seib FP. A Review of the Emerging Role of Silk for the Treatment of the Eye. Pharm Res. 2018 Nov 5;35(12):248. doi: 10.1007/s11095-018-2534-y.
- Background: PubMed 25938030Lee JS, Lee SU, Che CY, Lee JE. Comparison of cytotoxicity and wound healing effect of carboxymethylcellulose and hyaluronic acid on human corneal epithelial cells. Int J Ophthalmol. 2015 Apr 18;8(2):215-21. doi: 10.3980/j.issn.2222-3959.2015.02.01. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Epithelial Wound Healing, run by D&V FARMA srl at 1 site in Italy.
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 1 inclusion and 1 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 7 Mar 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Corneal re-ephitalization (time frame: 2 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06840990, which also lists 5 linked publications.
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 7 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.