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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06122428
• Other study ID #: CIT_001
• Status: Completed
• Start date: February 8, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: November 2023
• Source: University of Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 10, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	University of Naples Federico II	NAples

Sponsors (1)

Lead Sponsor	Collaborator
University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Ocular discomfort reduction mesured by OSDI test.	From enrollment to the end of treatment at 8 weeks
Secondary	Evaluate the reduction in Tear osmolarity	Tear osmolarity test. This measurement provides important information about tear composition.	From enrollment to the end of treatment at 8 weeks
Secondary	Measure the stability of the tear film	Tear Break-Up Time (TBUT) test This measures the stability of the tear film.	From enrollment to the end of treatment at 8 weeks
Secondary	Measure the tear production	Schirmer test I (without anesthetic) at 5 minutes. This measures tear production.	From enrollment to the end of treatment at 8 weeks
Secondary	Evaluate corneal staining	Biomicroscopic observation with white light and cobalt blue light according to the Oxford scheme. It provides information on corneal health.	From enrollment to the end of treatment at 8 weeks