Dry Eye Disease
Conditions
Keywords
dry eye disease, ribohyal, ocular surface, tear check
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. The product under investigation, Ribohyal®, had previously obtained certification and authorization from the relevant notified body for market sale (European patent n. 2228058) The primary questions it aimed to address were: * Did the use of Riboflavin-Enhanced Hyaluronic Acid Eye Drops result in a reduction of dry eye symptoms and an improvement in ocular comfort among patients with DED in a historical context? * Was Riboflavin-Enhanced Hyaluronic Acid Eye Drops historically more effective in reducing photophobia and enhancing tear film stability when compared to standard treatment? Participants in this retrospective analysis had historically: * Used either Riboflavin-Enhanced Hyaluronic Acid Eye Drops or a standard hyaluronic acid eye drop, based on their assigned group. * Historically reported their levels of ocular discomfort and photophobia at specified time points. * Undergone historical clinical examinations to assess tear film stability and osmolarity. Researchers conducted a retrospective analysis to compare the historical outcomes of the group using Riboflavin-Enhanced Hyaluronic Acid Eye Drops with the group using standard eye drops to determine if the former historically provided more significant improvements in dry eye symptoms and tear film stability.
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), 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, Schirmer test, tear meniscus measurement, and Non-invasive Break-Up Time (NIBUT). The Ocular Surface Disease Index (OSDI) score was historically recorded at various time points.
Interventions
DRUGmodified hyaluronic acid 0.1% covalently linked to Riboflavin
The patients used the eye drops no less than 3 times a day or no more than 6 times a day, according to their needs. They reported the instillation frequency (3/4 or 5/6 times per day) on the provided document
DRUGhyaluronic acid 0.1%
The patients used the eye drops no less than 3 times a day or no more than 6 times a day, according to their needs. They reported the instillation frequency (3/4 or 5/6 times per day) on the provided document
Sponsors
University of Naples
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the efficacy and safety of a new 0.1% sodium hyaluronate-riboflavin-conjugated (HAr®) artificial tear in treating ocular discomfort and improving tear film stability in patients with dry eye disease. | From enrollment to the end of treatment at 8 weeks | Ocular discomfort reduction mesured by OSDI test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the reduction in Tear osmolarity | From enrollment to the end of treatment at 8 weeks | Tear osmolarity test. This measurement provides important information about tear composition. |
| Measure the stability of the tear film | From enrollment to the end of treatment at 8 weeks | Tear Break-Up Time (TBUT) test This measures the stability of the tear film. |
| Measure the tear production | From enrollment to the end of treatment at 8 weeks | Schirmer test I (without anesthetic) at 5 minutes. This measures tear production. |
| Evaluate corneal staining | From enrollment to the end of treatment at 8 weeks | Biomicroscopic observation with white light and cobalt blue light according to the Oxford scheme. It provides information on corneal health. |
Countries
Italy
Outcome results
None listed