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OpenTrials
Completed

NCT Number: NCT06605365

Cross-linked CMC and Silk Proteins in Eye Disease

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.

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

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

  • Subjects affected by dry eye disease

Exclusion criteria

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

Treatment and study plan

CX-HA and CS

Device

Sterile Isotonic ophthalmic solution

Primary outcomes

  1. TBUT

    Time frame: 3 months

    Tear Breakup Time

Secondary outcomes

  1. OSDI

    Time frame: 3 months

    Ocular Surface Disease Index

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

D&V FARMA srl

Industry

Collaborators

  • San Giovanni Addolorata Hospital

Registry information

Official study title

Ophthalmic Solution in Drye Eye Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2024
Registry last updated
Sep 20, 2024

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.

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