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NCT06122428
Efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops in Treating Dry Eye Disease
trial testing modified hyaluronic acid 0.1% covalently linked to Riboflavin in Dry Eye Disease in 16 participants. Completed in 10 October 2022.
22 July 2022
Quick facts
| Lead sponsor | University of Naples |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 16 |
| Start date | 8 February 2022 |
| Primary completion | 22 July 2022 |
| Estimated completion | 10 October 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- modified hyaluronic acid 0.1% covalently linked to Riboflavin — full drug profile →
- hyaluronic acid 0.1% — full drug profile →
Conditions studied
- Dry Eye Disease — all drugs for Dry Eye Disease →
Sponsor
University of Naples
Who can join
18 and older, any sex, with Dry Eye Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Modified Sodium hyaluronate conjugated to riboflavin (Har® 0.1 %) as lubricant eyedrops in the treatment of dry eye: A prospective randomised study.
Caruso C, D'Andrea L, Rinaldi M, Senese I, et al · · 2024 · PMID 39170271 · DOI 10.1016/j.heliyon.2024.e35527
Verify or expand the search:
- PubMed search for NCT06122428
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Naples trials
Trials by the same sponsor.
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- NCT06073535 — The Use of Injectable-Platelet Rich Fibrin (i-PRF) in the Lower Third Molar Extraction · NA · unknown
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06122428 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Naples
- Last refreshed: 8 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06122428.
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