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

Ophthalmic Solution in Corneal Re-epithelization

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06840990
Acronym
CLCS
Enrollment
20
Registered
2025-02-21
Start date
2023-01-01
Completion date
2024-06-01
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Epithelial Wound Healing

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.

Interventions

DEVICECTRL

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

DEVICECXC-SP

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

Sponsors

San Giovanni Addolorata Hospital
CollaboratorOTHER
D&V FARMA srl
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Corneal re-ephitalization2 WEEKSTo evaluate and follow the corneal re-ephitalization process a topograph measuring epithelium thickness will be used.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026