Cross-linked CMC and Silk Proteins in Corneal Re-epithelization (CLCS)

D&V FARMA srl

Status: Completed

Conditions: Corneal Epithelial Wound Healing

Treatments: Device: CTRL; Device: CXC-SP

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06840990

COR-WH

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

CXC-SP

Description:

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.

Treatment:

Device: CXC-SP

CTRL

Description:

subjects who underwent either PRK , CXL , PTK , or experienced a corneal abrasion. The subjects were treated with the standard therapy only.

Treatment:

Device: CTRL