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

Sponsor

University of Naples (Other)

Overall Status

Completed

CT.gov ID

NCT06122428

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: modified hyaluronic acid 0.1% covalently linked to Riboflavin Drug: hyaluronic acid 0.1%

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 Design

Study Type:

Observational

Actual Enrollment :

16 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 8, 2022

Actual Primary Completion Date :

Jul 22, 2022

Actual Study Completion Date :

Oct 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	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
Group Y: (Control Group) Composed of 16 eyes (right or left) assigned for the use of HA 0.1% alone	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

Arm

Intervention/Treatment

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

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

Group Y: (Control Group)

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

Drug: hyaluronic acid 0.1%

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.