Cross-linked CMC and Silk Proteins 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.

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Key information

Conditions

Corneal Epithelial Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Giovanni-Addolorata Hospital

Rome, 00184, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

CTRL

Device

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

Primary outcomes

Corneal re-ephitalization

Time frame: 2 WEEKS

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

Sponsors and collaborators

Lead sponsor

D&V FARMA srl

Industry

Collaborators

San Giovanni Addolorata Hospital

Registry information

Official study title

Ophthalmic Solution in Corneal Re-epithelization

Acronym: CLCS

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Feb 21, 2025
Registry last updated: Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed