Cross-linked CMC and Silk Proteins in Eye Disease

September 18, 2024 updated by: D&V FARMA srl

Ophthalmic Solution in Drye Eye Patients

Data analyses and revision of the DED symptoms. 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 viscoelastic and hydrating, and wound healing properties.

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 affected by dry eye disease and treated with the ophthalmic solution containing CX-CMC and SP will be collected and analysed

Description

Inclusion Criteria:

  • Subjects affected by dry eye disease

Exclusion Criteria:

  • know allergies to CX-CMC
  • know allergies to SP

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 affected by dry eye disease are treated with the new ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP).
Device: CX-HA and CS
Sterile Isotonic ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TBUT
Time Frame: 3 months
Tear Breakup Time
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI
Time Frame: 3 months
Ocular Surface Disease Index
3 months
Wound Healing
Time Frame: 30 hours
Scratch test performed on cell lines using the "Ibidi Culture-Inserts". The test provides hinds on the ability of a cell line to cover a "wound" created in the monolayer. Results are given as % of the area covered
30 hours
UV and Blue light absorption
Time Frame: 0 hours
The ability of the solution to absorb UV and blue light will be evaluated via a spectrophotometer. The outcome will be measured in arbitrary units.
0 hours

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)

September 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR-TF

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

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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