NCT06840990|Completed
Cross-linked CMC and Silk Proteins in Corneal Re-epithelization
CLCS
Ophthalmic Solution in Corneal Re-epithelization
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CLCS
Ophthalmic Solution in Corneal Re-epithelization
Sponsor study identifier
observational
20
1 country
1
Study Start
January 1, 2023
Actual (reported)Primary Completion
May 1, 2024
Actual (reported)Study Completion
June 1, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2024
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2023
Actual (reported)May 1, 2024
Actual (reported)June 1, 2024
Actual (reported)February 18, 2025
Actual (reported)February 21, 2025
Actual (reported)Corneal re-ephitalization
To evaluate and follow the corneal re-ephitalization process a topograph measuring epithelium thickness will be used.
2 WEEKS
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.
subjects who underwent either PRK , CXL , PTK , or experienced a corneal abrasion. The subjects were treated with the standard therapy only.
Standard therapy plus sterile Isotonic ophthalmic solution based on CX-CMC and silk protein, istilled six time a day until complete healing.
Standard therapy plus sterile ophtalmic isotonic solution for six time a day until complete healing.
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.
San Giovanni-Addolorata Hospital
Rome, 00184, Italy
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.
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.
20 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2025
First Posted
February 21, 2025
Study Start
January 1, 2023
Actual (reported)Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
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.
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.
Primary Completion
May 1, 2024
Actual (reported)Study Completion
June 1, 2024
Actual (reported)Last Updated
March 7, 2025
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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