Status:
COMPLETED
Efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops in Treating Dry Eye Disease
Lead Sponsor:
University of Naples
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this retrospective study is to evaluate the historical effectiveness of Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) in the treatment of Dry Eye Disease (DED) among patients. ...
Detailed Description
In this retrospective study, the investigators have examined the historical therapeutic efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) in the treatment of Dry Eye Disease (DED),...
Eligibility Criteria
Inclusion
- Inclusion criteria for patient selection included a dry eye history of at least three months, OSDI score ≥ 23, and positivity in at least one eye for one or more of the following diagnostic criteria:
- Tear Break-Up Time (TBUT) \< 7 seconds
- Schirmer test I at 5 minutes \< 10 mm
- Corneal and/or conjunctival fluorescein staining
- Tear osmolarity \> 308 mOsm/L or a difference of at least 8 mOsm/L between both eyes.
- Exclusion Criteria:
- Age below 18 years
- Severe ocular surface affections
- Unilateral dry eye syndrome
- Refractive surgery performed within the last six months
- Eye surgery performed within the last three months
- Previous herpetic keratitis
- Signs of active corneal infection
- Systemic or topical steroid therapy within the last 30 days
- Topical therapy within the last 14 days
- Inability to understand the informed consent.
Exclusion
Key Trial Info
Start Date :
February 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06122428
Start Date
February 8 2022
End Date
October 10 2022
Last Update
November 8 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Naples Federico II
Naples, Italy, 80131