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

NCT06122428 | Completed

• 1 other identifier: CIT_001
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Keywords

dry eye disease; ribohyal; ocular surface; tear check

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluate the reduction in Tear osmolarity

  From enrollment to the end of treatment at 8 weeks

• Measure the stability of the tear film

  From enrollment to the end of treatment at 8 weeks

• Measure the tear production

  From enrollment to the end of treatment at 8 weeks

• Evaluate corneal staining

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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

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%

Interventions

modified hyaluronic acid 0.1% covalently linked to Riboflavin 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 X: Ribohyal Group

hyaluronic acid 0.1% 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study enrolled 16 consecutive patients with bilateral mild to severe Dry Eye Disease (DED) at the University of Naples Federico II, Italy. These participants were selected based on specific eligibility criteria, as outlined in other sections of the study. The selection aimed to ensure that the study population adequately represented individuals experiencing DED.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Naples: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 39170271 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 8, 2023
• Study Start: February 8, 2022
• Primary Completion: July 22, 2022
• Study Completion: October 10, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)