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NCT Number: NCT06122428

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples Federico II

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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.

    Time frame: From enrollment to the end of treatment at 8 weeks

    Ocular discomfort reduction mesured by OSDI test.

Secondary outcomes

  1. Evaluate the reduction in Tear osmolarity

    Time frame: From enrollment to the end of treatment at 8 weeks

    Tear osmolarity test. This measurement provides important information about tear composition.

  2. Measure the stability of the tear film

    Time frame: From enrollment to the end of treatment at 8 weeks

    Tear Break-Up Time (TBUT) test This measures the stability of the tear film.

  3. Measure the tear production

    Time frame: From enrollment to the end of treatment at 8 weeks

    Schirmer test I (without anesthetic) at 5 minutes. This measures tear production.

  4. Evaluate corneal staining

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Naples

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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