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

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: modified hyaluronic acid 0.1% covalently linked to Riboflavin; Drug: hyaluronic acid 0.1%

• Registration Number: NCT06122428
• Lead Sponsor: University of Naples

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.

Study Timeline

• Study Start: 2022-02-08
• Primary Completion: 2022-07-22
• Study Completion: 2022-10-10
• Study First Submitted: 2023-10-12
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-02
• Last Update Submitted: 2023-11-02
• Study First Posted: 2023-11-08
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group X: Ribohyal Group	modified hyaluronic acid 0.1% covalently linked to Riboflavin	Composed of 16 eyes (right or left) assigned for the use of modified hyaluronic acid, HAr® 0.1%, covalently linked to Riboflavin
Group Y: (Control Group)	hyaluronic acid 0.1%	Composed of 16 eyes (right or left) assigned for the use of HA 0.1% alone

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 NAples, Italy