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
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.
• Patient written informed consent to participate in the study obtained according to Good Clinical Practice (GCP);
• Male and female patients aged ≥18 years;
• 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;
• 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;
• 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;
• A Schirmer test value \< 10 mm;
• A TFBUT value ≥ 5 sec;
• 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;
• 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.