Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease

NCT06190054 | Unknown

• 1 other identifier: IS44-21-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

This is a profit, multicentric, prospective, single-arm, open-label, non-pharmacological clinical investigation. Patients with diagnosis of moderate to severe dry eye disease with asthenopia and accommodative effort will receive MERAMIRT®, 1-2 drop per eye 3 times a day for 90 days.

Conditions

Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users

Outcome Measures

Primary Outcomes (1)

• Efficacy Assessment of dry eye symptoms from baseline

  Change from baseline in TBUT value. The TBUT 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 TBUT value will be the average of the 2 or 3 measurements

  Day 30

Secondary Outcomes (7)

• Efficacy Assessment of dry eye symptoms from baseline

  Day 30 and Day 60

• Assessment of ocular surface health from baseline

  Day 30, Day 60 and Day 90

• Efficacy Assesment of drye eye symptoms in visual-related function from baseline

  Day 30, Day 60 and Day 90

• Efficacy Assessment of patient-subjective evaluation of ocular symptoms from baseline

  Day 90

• Efficacy Assessment of visual acuity from baseline

  Day 90

Study Arms (1)

MERAMIRT

EXPERIMENTAL

Patients with diagnosis of moderate to severe dry eye disease with asthenopia and accommodative effort will receive MERAMIRT®, 1-2 drop per eye 3 times a day for 90 days.

Device: MERAMIRT

Interventions

MERAMIRT DEVICE

MERAMIRT®, a class IIa medical device, is indicated for hydration and lubrication of the ocular surface under conditions of eye disorders caused by environmental, visual and mechanical stress, also due to asthenopia and accommodation effort. The main component of MERAMIRT® are Hydroxypropyl-methylcellulose (HPMC 0.3%) and Inositol (0.1%). HPMC has the property of moisturizing and lubricating the eye. Inositol is used with an antioxidant role

MERAMIRT

Eligibility Criteria

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

You may qualify if:

• Patients having signed written informed consent to participate in the study obtained according to Good Clinical Practice (GCP);
• Patients having an age ≥ 18 years;
• Patients with a diagnosis of moderate or severe dry eye disease (according to TFOS DEWS II definition) with asthenopia and accommodative effort, assessed through the following exams: visual acuity, intraocular pressure, slit lamp examination, Schirmer's test, TBUT, corneal and conjunctival staining (Oxford Staining Scheme), CVS-Q and SPEED questionnaires or previous diagnosis of dry eye disease not treated in the previous 15 days;
• Schirmer's test ≤ 10 mm;
• TBUT ≤ 10 sec;
• Fluorescein staining of the cornea and conjunctiva (Oxford scale value ≤ 2); In case of bilateral dry eye syndrome, only the worst eye, defined as the eye with the higher severity of impairment according to the Investigator'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.
• Use of video terminal display more than 4 hours daily, at least five days per week (minimum twenty hours a week);
• Patients being able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned study visits according to the time limits), based on Investigator's judgment;
• Patients agree to not apply during the study any other eye drops product that could interfere (particularly, corticosteroid and antibiotics eye drops) with the investigational product. Use of contact lenses during then study is permitted, but they are to be removed in the 24 hours preceding each visit and prior each MERAMIRT® application;
• Note: According to the definition of Note 3 of ICH M3 Guideline a highly effective method is defined as those 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:

• Patients under treatment with any therapy (drug, medical device or any other eye drops product, particularly, corticosteroid and antibiotics eye drops) that could interfere with the assessment of the efficacy or incidence of adverse events;
• Patients with 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 investigation procedures or the assessment of the efficacy or the interpretation of the investigation results or the incidence of adverse events;
• Patients suffering from diseases or conditions that could interfere with the assessment of the efficacy or incidence of adverse events, such as uncorrected presbyopia, myopia astigmatism, hyperopia;
• Patients with hypersensitivity and/or allergy to any of the MERAMIRT® ingredients;
• Patients not giving their written informed consent;
• Patients not being able to apply during the study any eye drops product;
• Patients participating to another clinical study/investigation at the same time as the present investigation or within 30 days;
• Patients who have history of drug, medication or alcohol abuse or addiction.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (4)

ASST Bergamo Est-Ospedale M.O.A. Locatelli

Piario, Bergamo, 24020, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Biomedico

Roma, RO, 00128, Italy

NOT YET RECRUITING

AOU- San Giovanni di Dio e Ruggi d'Aragona

Salerno, 84131, Italy

RECRUITING

Ospedale Bel Colle

Viterbo, 01100, Italy

RECRUITING

Study Officials

• Nicola Rosa, MD

  AOU-San Giovanni di Dio e Ruggi d'Aragona- Salerno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Giordan

CONTACT

+390498232512; ngriordan@fidiapharma.it

Michela Costantino

CONTACT

+390498232107; mcostantino@fidiapharma.it

Study Design

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

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: February 6, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)