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

NCT ID: NCT06122428

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2022-10-10

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.

Conditions

Dry Eye Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group X: Ribohyal Group

Composed of 16 eyes (right or left) assigned for the use of modified hyaluronic acid, HAr® 0.1%, covalently linked to Riboflavin

modified hyaluronic acid 0.1% covalently linked to Riboflavin

Intervention Type: DRUG

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

Group Y: (Control Group)

Composed of 16 eyes (right or left) assigned for the use of HA 0.1% alone

hyaluronic acid 0.1%

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Naples

OTHER

Sponsor Role: lead

Responsible Party

Luca D'Andrea

Prinicipal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Naples Federico II

Naples, , Italy

Countries

Italy

References

Caruso C, D'Andrea L, Rinaldi M, Senese I, Piscopo R, Costagliola C. Modified Sodium hyaluronate conjugated to riboflavin (Har(R) 0.1 %) as lubricant eyedrops in the treatment of dry eye: A prospective randomised study. Heliyon. 2024 Jul 31;10(15):e35527. doi: 10.1016/j.heliyon.2024.e35527. eCollection 2024 Aug 15.

Reference Type: DERIVED

PMID: 39170271 (View on PubMed)

Other Identifiers

CIT_001

Identifier Type: -

Identifier Source: org_study_id