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

March 6, 2025 updated by: D&V FARMA srl

Ophthalmic Solution 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00184
        • San Giovanni-Addolorata Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Standard therapy plus sterile Isotonic ophthalmic solution based on CX-CMC and silk protein, istilled six time a day until complete healing.
CTRL
subjects who underwent either PRK , CXL , PTK , or experienced a corneal abrasion. The subjects were treated with the standard therapy only.
Device: CTRL
Standard therapy plus sterile ophtalmic isotonic solution for six time a day until complete healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal re-ephitalization
Time Frame: 2 WEEKS
To evaluate and follow the corneal re-ephitalization process a topograph measuring epithelium thickness will be used.
2 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D&V FARMA srl

Collaborators

San Giovanni Addolorata Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • COR-WH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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