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CompletedNCT06840990CLCSUpdated Mar 7, 2025

Cross-linked CMC and Silk Proteins in Corneal Re-epithelization

An observational study in Corneal Epithelial Wound Healing, sponsored by D&V FARMA srl. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by D&V FARMA srl · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
20
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Corneal Epithelial Wound Healing
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In context

Lead sponsor

D&V FARMA srl is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
20 participants (actual)
Target follow-up
2 Weeks
Patient registry
Yes

Groups and cohorts

  • 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.

    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.

    Device: CTRL

Interventions

  • DeviceCXC-SP

    Standard therapy plus sterile Isotonic ophthalmic solution based on CX-CMC and silk protein, istilled six time a day until complete healing.

  • DeviceCTRL

    Standard therapy plus sterile ophtalmic isotonic solution for six time a day until complete healing.

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What researchers measure

Primary outcomes

  1. Corneal re-ephitalization

    To evaluate and follow the corneal re-ephitalization process a topograph measuring epithelium thickness will be used.

    Time frame: 2 WEEKS

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Study locations

1 site
  • San Giovanni-Addolorata Hospital
    Rome, 00184, Italy
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References and documents

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 29155856 ↗
  • Garrett 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 17389485 ↗
  • Kundu 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 20566044 ↗
  • Tran 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 30397820 ↗
  • Lee 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06840990
Lead sponsor
D&V FARMA srl
Collaborators
San Giovanni Addolorata Hospital
Responsible party
Sponsor
First posted
Feb 21, 2025
Start date
Jan 1, 2023
Primary completion
May 1, 2024
Completion
Jun 1, 2024
Last update
Mar 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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