Clinical trial NCT06122428: Efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops in Treating Dry Eye Disease
Official title: Modified Sodium Hyaluronate Conjugated to Riboflavin (HAr® 0.1%) as Lubricant Eyedrops in the Treatment of Dry Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease
Keywords: dry eye disease
ribohyal
ocular surface
tear check
Lead sponsor: University of Naples
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Evaluate the reduction in Tear osmolarity
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Measure the stability of the tear film
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Measure the tear production
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Evaluate corneal staining
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: NAples
country: Italy
facility: University of Naples Federico II
Study officials:
References: