Comparing two eye gels for treating moderate to severe dry eye syndrome

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

This study is testing if a new eye gel called Myrialen® works just as well as another gel, Recugel®, for helping people with moderate to severe dry eye syndrome feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fidia Farmaceutici s.p.a. (Industry-sponsored)
• Locations: 3 sites (Chieti, Pescara and 2 other locations)
• Trial ID: NCT06210373 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the efficacy and safety of two eye gel products, Myrialen® and Recugel®, both containing 5% dexpanthenol, in patients suffering from moderate to severe dry eye syndrome. The study is designed as a multicentric, randomized, non-inferiority trial, aiming to demonstrate that Myrialen® gel is at least as effective as Recugel® in improving the condition of the corneal and conjunctival surfaces. A total of 110 patients will be enrolled, with assessments conducted through slit lamp biomicroscopy and various ocular tests to measure improvements in dry eye symptoms. The study seeks to fill a gap in the literature regarding the use of dexpanthenol in managing dry eye disease.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have a new or untreated diagnosis of moderate to severe dry eye syndrome.

Not a fit: Patients who have been treated for dry eye syndrome in the past 15 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a new effective treatment option for managing moderate to severe dry eye syndrome.

How similar studies have performed: While there is limited literature on dexpanthenol for dry eye management, previous studies have shown promising results with similar approaches.

Eligibility criteria

Inclusion Criteria:

1. Patient written informed consent to participate in the study obtained according to Good Clinical Practice (GCP);
2. Male and female patients aged ≥18 years;
3. Patients with new diagnosis of dry eye syndrome (according to Tear Film and Ocular Surface Society \[TFOS\] Dry Eye Workshop \[DEWS\] II definition), or previous diagnosis of dry eye syndrome not treated in the previous 15 days;
4. Diagnosis of dry eye syndrome performed through the following exams: slit lamp examination (SLE), Impact of Dry Eye on Everyday Living (IDEEL) questionnaire, tear (lacrimal) meniscus exam, Schirmer's test, Tear Film Break-Up Time (TFBUT), fluorescein and lissamine green staining of the cornea and conjunctiva (respectively). In case of bilateral dry eye syndrome, only the worst eye, defined as the eye with the higher severity of impairment according to theInvestigator's judgment based on the above exams, will be considered for assessments (although both eyes will be treated). In the case of bilateral dry eye syndrome with both eyes having the same level of impairment, the right eye will be considered for assessments by convention;
5. Sodium fluorescein and lissamine green staining score of the cornea and conjunctiva(respectively) ≥ 2 National Eye Institute (NEI) grid, defined as the sum of 5 areas per eye using a 0 (normal) to 3 (severe) scale) in the worst eye for the corneal staining and the sum of 6 areas per eye using a 0 (normal) to 3 (severe) scale in the worst eye for the conjunctival staining;
6. A Schirmer test value \< 10 mm;
7. A TFBUT value ≥ 5 sec;
8. Patient able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator's judgment;
9. Females of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status - or not postmenopausal for at least one year) must have a negative urine pregnancy test result at Screening and must use an appropriate method of contraception for at least 30 days before inclusion in the study and during the whole study period, according to the definition in ICH M3 Guideline:

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:

1. Any ocular disease other than dry eye syndrome requiring treatment with ophthalmological topical medications with re-epithelizing, trophic, anti-infective or anti-inflammatory effect (e.g. antibiotics, corticosteroids, gel re-epithelizing, platelet-rich plasma, autologous serum, medication with vitamin A, hyaluronic acid-based products) in either eye at the time of study enrolment and in the previous 30 days;
2. Any active ocular infection or active inflammation in either eye unrelated to dry eye syndrome;
3. Presence or history of any systemic or ocular disorder, condition or disease (with particular attention to malignancies and neuro-oncological diseases) that, according to Investigator's judgment, can interfere with the conduct of the required study procedures or the assessment of the efficacy or the interpretation of the study results or the incidence of adverse events;
4. Use of therapeutic or refractive contact lenses in either eye in the previous 20 days and at the time of study enrolment;
5. History of ocular surgery in either eye, excluding corneal refractive or cataract procedures, within 90 days of study enrolment;
6. Treatment with any other therapy that, according to Investigator's judgment, could interfere with the assessment of the efficacy or incidence of adverse events;
7. Hypersensitivity and/or allergy to any of Myrialen® gel and/or Recugel® ingredients;
8. Women pregnant or breastfeeding or women who could become pregnant and are not using effective contraception;
9. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the investigation;
10. Participation in another clinical investigation within the past 30 days or previous enrolment in this investigation.

Where this trial is running

Chieti, Pescara and 2 other locations

• Ospdale SS.Annunziata-Università degli Studi G.d'Annunzio — Chieti, Pescara, Italy (Recruiting)
• Università degli studi Federico II — Napoli, Italy (Recruiting)
• Humanitas Gradenigo — Torino, Italy (Recruiting)

Study contacts

• Principal investigator: Leonardo Mastropasqua, MD — Ospedale SS. Annunziata- Università degli studi G. d'Annunzio-Chieti
• Study coordinator: Nicola Giordan, MD

Conditions Dry Eye Disease