An interventional study of Myrialen Gel and Recugel in Dry Eye Disease, sponsored by Fidia Farmaceutici s.p.a.. Completed at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Fidia Farmaceutici s.p.a. · Not applicable, Interventional, and Treatment
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.
There is scarce documentation in literature on the effects of dexpanthenol in the management of DED. In a randomized, double-blind, placebo-controlled study that evaluated the effect of dexpanthenol-containing artificial tears in 50 patients with dry eyes, patients receiving the active ingredient had significant improvement of disturbances of the corneal epithelial permeability (as measured by fluorophotometry and Schirmer test, Rose Bengal staining, TFBUT), compared to the dexpanthenol-free eyes drops. Despite the scarce literature documentation, the use of 5% dexpanthenol, which stimulates the processes of reparative regeneration and possesses an anti-inflammatory effect, is actually considered as one of the promising directions in the management of patients with DED. Dexpanthenol has also been developed as a component of a contact lens system that controls its release as osmoprotectant and moisturizing agent with the aim to reduce symptoms of ocular dryness.
Based on this background, this investigation has been designed to compare the effects of the investigational device Myrialen® gel with another device containing 5% dexpanthenol, i.e. Recugel® eye gel, in the treatment of patients with moderate to severe dry eye syndrome. In particular, the main objective of this investigation is to demonstrate that the test device Myrialen®gel will be non-inferior to the reference device Recugel® in improving corneal and conjunctival surface state.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.
This study's enrollment of 125 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Fidia Farmaceutici s.p.a. is the lead sponsor of 30 studies on the registry; 8 are open to participants now.
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A highly effective method is defined as that which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Highly effective birth control methods include:
combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.
Exclusion Criteria:
Myrialen® gel: sterile ophthalmic gel containing 5% dexpanthenol
Device: Myrialen Gel
Recugel®: sterile ophthalmic gel containing 5% dexpanthenol
Device: Recugel
Myrialen Gel will be instilled as 1 drop per eye 3 times a day and one drop per eye before going to bed in the conjunctival sac for 30 days.In case of bilateral dry eye syndrome, both eyes will be treated. In case of monolateral dry eye syndrome, the decision to treat both eyes will be taken according to the Investigator's judgment.
Also known as: Dexpanthenol 5%
Recugel will be instilled as 1 drop per eye 3 times a day and one drop per eye before going to bed in the conjunctival sac for 30 days. In case of bilateral dry eye syndrome, both eyes will be treated. In case of monolateral dry eye syndrome, the decision to treat both eyes will be taken according to the Investigator's judgment.
Also known as: Dexpanthenol 5%
Efficacy assessment through National Eye Institute (NEI) total score compared to baseline
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 area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva.
Time frame: Day 30
Efficacy assessment through National Eye Institute (NEI) total score compared to baseline
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 area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva.
Time frame: Day 7
Efficacy assessment through National Eye Institute (NEI) corneal score compared to baseline
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.
Time frame: Day 7 and Day 30
Efficacy assessment through National Eye Institute (NEI) conjunctival score compared to baseline
The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. . Both nasally and temporally, the conjunctiva will be divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva.
Time frame: Day 7 and Day 30
Assessment of Changes in impact of Dry Eye on Everyday living (IDEEL) questionnaire (symptom-bother and impact on daily life modules) from baseline
The IDEEL is divided into different sectionsa and only two will be considered in patient evaluation. The "Dry Eye Symptom-Bother" module includes 20 items: Item 1 from 0 "none of the time" to 4 "all of the time"; Items 2-from 1 "not at all" to 4 "very much". Score 0="I did not have this symptom / Not applicable"; and the "Dry Eye Impact on Daily Life" module composed of 3 sections: dry eye on daily living activities (9 items), emotional impact (12 items) and impact on work (6 items).Items 1-9 are scored on a 5-point Likert-like scale from 1 "all of the time" to 5 "none of the time". Items 10-21, 23-27 are scored on a 5-point Likert-like scale from 0 "all of the time" to 4 "none of the time". Item 22 is scored on a dichotomous scale: 1 "Yes", 0 "No". This item is not included in the calculation of the scores.
Time frame: Day 30
Assessment of Changes in Tear-Film Break-Up Time from baseline
The tear film is observed under cobalt-blue filtered light of the slit lamp biomicroscope and the time that elapses between the last blink and appearance of the first break in the tear film is recorded with a stopwatch (a break is seen as a dark spot in a sea of blue). TFBUT results of less than 10 seconds are consistent with dry eyes. The TFBUT will be measured twice during the first minute after the instillation of the fluorescein. If the 2 readings differ by more than 2 seconds a third reading will be taken. The TFBUT value will be the average of the 2 or 3 measurements.
Time frame: Day 7 and Day 30
Assessment of quantitative normalization of the tear film from baseline
Change in Schirmer's Test values from baseline. The Schirmer's test measures the quantity of total tear secretion, including reflex and basal tears, produced by the eye. A 35 mm x 5 mm size filter paper strip is used to measure the amount of tears that are produced over a period of 5 minutes. The wet portion of the strip is measured in millimeters. The test is done under ambient light. The patient is instructed to look forward and to blink normally during the course of the test. Normal mean test values range from 8 mm to 33 mm, but an accepted normal value is greater than 10 mm. Patients with dry eyes have wetting values of less than 5 mm in 5 minutes.
Time frame: Day 7 and Day 30
Assessment of qualitative normalization of the tear film from baseline
Changes will be evaluated through the tear meniscus height. The tear (lacrimal) meniscus examination is conducted using slit-lamp biomicroscopy (narrow slit and low intensity light) and observing the tear (lacrimal) meniscus height. Values are considered normal if within the 0.3 to 0.5-mm range.
Time frame: Day 30
Assessment of changes in visual acuity from baseline
Visual function will be assessed by distance visual acuity measurement. Both uncorrected distance visual acuity (UNVA, vision with no extraocular optical correction) and best corrected distance visual acuity (BCVA, defined as obtained with the best possible refractive correction) will be measured using the Snellen chart. Visual acuity values will be expressed in decimal, fraction or logMAR. All assessments will be performed using standard charts and procedures at specified visual angle, illumination and contrast. Current refraction will be determined prior to visual acuity testing to obtain best-corrected vision
Time frame: Day 30
Assessment of incidence of treatment-emergent adverse events
Safety and tolerabiltiy will be assessed through the analysis of Incidence and nature of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs); Incidence and nature of Adverse Device Effects (ADEs) and serious ADEs (SADEs) during the entire investigation duration; Incidence and nature of Investigational Medical Device Deficiencies (IMDDs) during the entire investigation duration.
Time frame: Day 30
Changes in confocal microscopy of density of dendritic cells from baseline
The changes will be evaluated through the use of confocal microscopy. The density of dendritic cells at the level of the sub-epithelial basal membrane evaluated in the central cornea (number of cells/mm2) will be evaluated according to single-layer epithelium, two cellular layers evidenced, more than two cellular layers evidenced.
Time frame: Day 30
Changes in confocal microscopy in stratification of the epithelium from baseline
The changes will be evaluated through the use of confocal microscopy. The stratification of the epithelium will be evaluated according to single-layer epithelium, two cellular layers evidenced, more than two cellular layers evidenced.
Time frame: Day 30
Plan to share: No
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Fidia Farmaceutici s.p.a.