NCT06840990CompletedNot Applicable
Ophthalmic Solution in Corneal Re-epithelization
D&V FARMA srl1 site in 1 country20 target enrollmentStarted: January 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Corneal re-ephitalization
Study Overview
Brief Summary
Data analyses and revision of the corneal re-epithelization in patients who underwent either PRK (Photorefractive Keratectomy), CXL (Corneal Cross-Linking), PTK (phototherapeutic keratectomy), or experienced a corneal abrasion. 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 wound healing properties in the ophtalmic field. This new ophthalmic solution is the first on the market formulated with a CX-CMC and SP.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who had undergone surgical procedures involving de-epithelialization, which included CXL, PRK, and PTK, as well as those with a first diagnosis of corneal abrasion
Exclusion Criteria
- •patients with known allergies or hypersensitivity to any components of the tested formulations or standard therapies, or those requiring different treatments compared to the rest of the study population
Outcomes
Primary Outcomes
Corneal re-ephitalization
Time Frame: 2 WEEKS
To evaluate and follow the corneal re-ephitalization process a topograph measuring epithelium thickness will be used.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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