Cross-linked CMC and Silk Proteins in Eye Disease

Ophthalmic Solution in Drye Eye Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06605365

Enrollment

Registered

2024-09-20

Start date

2021-09-01

Completion date

2022-09-01

Last updated

2024-09-20

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

Conditions

Dry Eye Disease (DED)

Brief summary

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.

Interventions

DEVICECX-HA and CS

Sterile Isotonic ophthalmic solution

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects affected by dry eye disease

Exclusion criteria

* know allergies to CX-CMC * know allergies to SP

Design outcomes

Primary

Measure	Time frame	Description
TBUT	3 months	Tear Breakup Time

Secondary

Measure	Time frame	Description
OSDI	3 months	Ocular Surface Disease Index
Wound Healing	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
UV and Blue light absorption	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.

Countries

Italy

Outcome results

None listed

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