Efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops in Treating Dry Eye Disease
Launched by UNIVERSITY OF NAPLES · Nov 2, 2023
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
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), adhering to good clinical practice principles.
Participants were historically divided into two groups:
* Group X: received Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) (Ribohyal Group).
* Group Y: received standard HA 0.1% eye drops (Control Group).
The historical outcome measures included the retrospective assessments of osmolarity, Tear Break-Up Time (TBUT), corneal staining,...
Gender
ALL
Eligibility criteria
- 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.
About University Of Naples
The University of Naples is a prestigious academic institution dedicated to advancing medical research and clinical education. Renowned for its commitment to innovation and excellence, the university actively sponsors clinical trials aimed at exploring new therapeutic approaches and improving patient outcomes. Leveraging its multidisciplinary expertise and state-of-the-art facilities, the University of Naples fosters collaborative research efforts that bridge the gap between scientific discovery and practical application in healthcare. Through its rigorous clinical trials, the university seeks to contribute significantly to the medical community and enhance the quality of life for patients both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Naples, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported