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

NCT06840990 | Completed

• 1 other identifier: COR-WH
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Epithelial Wound Healing

Outcome Measures

Primary Outcomes (1)

• Corneal re-ephitalization

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

  2 WEEKS

Study Arms (2)

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

CXC-SP DEVICE

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

CXC-SP

CTRL DEVICE

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

CTRL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• D&V FARMA srl: lead
• San Giovanni Addolorata Hospital: collaborator

Study Sites (1)

San Giovanni-Addolorata Hospital

Rome, 00184, Italy

Location

Related Publications (5)

• 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.

  PMID: 29155856 BACKGROUND

• 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.

  PMID: 17389485 BACKGROUND

• 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.

  PMID: 20566044 BACKGROUND

• 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.

  PMID: 30397820 BACKGROUND

• 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.

  PMID: 25938030 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: January 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 7, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)