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NCT06210373
A Prospective, Multicentric, Randomized, Non-inferiority, Controlled, Open-label Clinical Investigation to Evaluate the Efficacy and Safety of the Use of Myrialen® Gel vs.Recugel®, Two Eye Gel Products Containing 5% Dexpanthenol, in Patients With Moderate to Severe Dry Eye Syndrome
NA trial testing Myrialen Gel in Dry Eye Disease in 124 participants. Status unknown.
1 November 2024
Quick facts
| Lead sponsor | Fidia Farmaceutici s.p.a. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 16 November 2022 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- Myrialen Gel
- Recugel
Conditions studied
- Dry Eye Disease — all drugs for Dry Eye Disease →
Sponsor
Fidia Farmaceutici s.p.a. — full company profile →
Who can join
18 and older, any sex, with Dry Eye Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Efficacy assessment through National Eye Institute (NEI) total score compared to baseline
Time frame: Day 30
The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which will be scored on a scale of 0-3, with a maximal score of 15. Both nasally and temporally, the conjunctiva will be divided into a superior paralimbal area, an inferior paralimbal
Sponsor's own description
The prospective, multicentric, randomized, non-inferiority, controlled, open-label clinical investigation will evaluate the efficacy and safety of the use of Myrialen® gel vs. Recugel®, two eye gel products containing 5% dexpanthenol, in patients with moderate to severe dry eye syndrome. A total of 110 evaluable patients (55 in each treatment group), ≥18 years of age, will be required for data analysis. A total of 124 patients (62 in each treatment group) will be randomized to replace potential early withdrawals or non-evaluable patients.The primary objective of this investigation is to demonstrate non-inferior efficacy of Test Myrialen® gel over the Reference Recugel® in improving corneal and conjunctival surface state, assessed through slit lamp biomicroscopy examination, in patients with moderate to severe dry eye syndrome.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06210373
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT04946721 — 2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD · recruiting
- NCT06696625 — Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye · NA · recruiting
Other Fidia Farmaceutici s.p.a. trials
Trials by the same sponsor.
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- NCT06108999 — Management of Acute and Chronic Wounds With Hyaluronic Acid · NA · recruiting
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- NCT06103812 — Evaluate Performance and Safety of Hyalo4 Skin in Acute and Chronic Wounds · unknown
- NCT04757038 — An Open Label, Randomized-controlled Trial to Assess Efficacy Safety of HYALODISC With Physical Exercise Program · NA · unknown
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 NCT06210373 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fidia Farmaceutici s.p.a.
- Last refreshed: 26 July 2024
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/NCT06210373.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing