NCT06122428

Efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops in Treating Dry Eye Disease

Modified Sodium Hyaluronate Conjugated to Riboflavin (HAr® 0.1%) as Lubricant Eyedrops in the Treatment of Dry Eye

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: University of Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	modified 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
DRUG	hyaluronic 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

Timeline

• Start date: 2022-02-08
• Primary completion: 2022-07-22
• Completion: 2022-10-10
• First posted: 2023-11-08
• Last updated: 2023-11-08

Locations

1 site across 1 country: Italy