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OpenTrials
Completed

NCT Number: NCT06573606

Ophthalmic Solution in Diabetic Corneal Alteration

Data analyses and revision of the DED symptoms in diabetic subjects. A novel ophthalmic solution containing cross-linked ha (CX-HA) and Chondroitin sulphate (CS) has been made available on the market.

Both molecules have been widely studied for their viscoelastic and hydrating properties.

Nevertheless, the use of CS in ophthalmology has been limited since, routinely, the molecule is of animal origins.

This new ophthalmic solution is the first on the market formulated with a CS of non-animal origin.

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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

  • Diabetic Subjects affected by dry eye disease

Exclusion criteria

  • know allergies to CX-HA
  • know allergies to CS

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. Corneal Sensitivity

    Time frame: 3 months

    measured via the "Luneau Cochet-Bonnet Aesthesiometer", results are expressed in cm

  3. 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

Sponsors and collaborators

Lead sponsor

D&V FARMA srl

Industry

Collaborators

  • San Giovanni Addolorata Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2024
Registry last updated
Aug 29, 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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