Assessment of Efficacy and Safety of the Use of Two Eye Gel Products Containing 5% Dexpanthenol in Patients With Moderate to Severe Dry Eye Syndrome

NCT06210373 | Unknown

• 1 other identifier: IS57-21-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 30

Secondary Outcomes (9)

• Efficacy assessment through National Eye Institute (NEI) total score compared to baseline

  Day 7

• Efficacy assessment through National Eye Institute (NEI) corneal score compared to baseline

  Day 7 and Day 30

• Efficacy assessment through National Eye Institute (NEI) conjunctival score compared to baseline

  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

  Day 30

• Assessment of Changes in Tear-Film Break-Up Time from baseline

  Day 7 and Day 30

Other Outcomes (2)

• Changes in confocal microscopy of density of dendritic cells from baseline

  Day 30

• Changes in confocal microscopy in stratification of the epithelium from baseline

  Day 30

Study Arms (2)

Myrialen Gel Group

EXPERIMENTAL

Myrialen® gel: sterile ophthalmic gel containing 5% dexpanthenol

Device: Myrialen Gel

Recugel Group

ACTIVE COMPARATOR

Recugel®: sterile ophthalmic gel containing 5% dexpanthenol

Device: Recugel

Interventions

Myrialen Gel DEVICE

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%

Myrialen Gel Group

Recugel DEVICE

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%

Recugel Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• Any active ocular infection or active inflammation in either eye unrelated to dry eye syndrome;
• 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;
• Use of therapeutic or refractive contact lenses in either eye in the previous 20 days and at the time of study enrolment;
• History of ocular surgery in either eye, excluding corneal refractive or cataract procedures, within 90 days of study enrolment;
• Treatment with any other therapy that, according to Investigator's judgment, could interfere with the assessment of the efficacy or incidence of adverse events;
• Hypersensitivity and/or allergy to any of Myrialen® gel and/or Recugel® ingredients;
• Women pregnant or breastfeeding or women who could become pregnant and are not using effective contraception;
• Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the investigation;
• Participation in another clinical investigation within the past 30 days or previous enrolment in this investigation.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (3)

Ospdale SS.Annunziata-Università degli Studi G.d'Annunzio

Chieti, Pescara, 66100, Italy

RECRUITING

Università degli studi Federico II

Napoli, 80131, Italy

RECRUITING

Humanitas Gradenigo

Torino, 10153, Italy

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Leonardo Mastropasqua, MD

  Ospedale SS. Annunziata- Università degli studi G. d'Annunzio-Chieti

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Giordan, MD

CONTACT

+390498232512; ngriordan@fidiapharma.it

Michela Costantino

CONTACT

+390498232107; mcostantino@fidiapharma.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 18, 2024
• Study Start: November 16, 2022
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 29, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)