Clinical trial NCT06605365: Cross-linked CMC and Silk Proteins in Eye Disease
Official title: Ophthalmic Solution in Drye Eye Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease (DED)
Lead sponsor: D&V FARMA srl
Sponsor class: INDUSTRY
Collaborators: name: San Giovanni Addolorata Hospital
First posted: 2024-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.


Eligibility criteria: Inclusion Criteria:

* Subjects affected by dry eye disease

Exclusion Criteria:

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

Primary outcomes:
measure: TBUT
timeFrame: 3 months
Secondary outcomes:
measure: OSDI
timeFrame: 3 months
measure: Wound Healing
timeFrame: 30 hours
measure: UV and Blue light absorption
timeFrame: 0 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Giovanni-Addolorata Hospital
Study officials:
References:
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