Clinical trial NCT06190054: Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease
Official title: Evaluation of the Efficacy and Safety of an Eye Drops With Hydroxypropyl-methylcellulose and Inositol as Principal Components (MERAMIRT®) in the Treatment of Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Hypromellose is a polymer that has the property to tick and stabilize the tear film on the corneal surface, which create a protective, transparent and viscoelastic layer. Inositol, as other osmolytes, may contribute to counteract the oxidant action on free radicals produced in condition of asthenopia and accommodative effort. Such activity may indirectly support the muscular metabolic processes favoring the contractile response.

MERAMIRT® is a hydrating and lubricant tear replacement indicated in ocular isturbances caused by environmental, visual and mechanic stress, also due to asthenopia and accommodative effort.

In a small, open-label study, a 0.3% hypromellose eye gel showed statistically significant effects in relieving ocular symptoms and in improving ocular comfort in patients with dry eye syndrome.

Another recent study showed that treatment with punctual occlusion using hypromellose 2% was associated with a significant reduction in signs and symptoms in patients with dry eye.

Based on the preliminary available background on the use of hypromellose in the management of dry eye syndrome, this investigation has been designed to assess the efficacy and safety of a sterile ophthalmic solution that contains hypromellose and inositol (MERAMIRT®), in a sample of VDT users suffering of moderate or severe DED with asthenopia and accommodative effort.

Eligibility criteria: Inclusion Criteria:

1. Patients having signed written informed consent to participate in the study obtained according to Good Clinical Practice (GCP);
2. Patients having an age ≥ 18 years;
3. 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;
4. Schirmer's test ≤ 10 mm;
5. TBUT ≤ 10 sec;
6. 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.
7. Use of video terminal display more than 4 hours daily, at least five days per week (minimum twenty hours a week);
8. 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;
9. 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;
10. Female patients having a negative urine pregnancy test result at screening and using an appropriate method of contraception for at least 30 days before inclusion and during the whole investigation period, according to the definition of Note 3 of ICH M3 Guideline\*, if females of childbearing potential (i.e., not permanently sterilized - post hysterectomy or tubal ligation status - or not postmenopausal):

    * 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.

Exclusion Criteria:

1. 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;
2. 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;
3. 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;
4. Patients with hypersensitivity and/or allergy to any of the MERAMIRT® ingredients;
5. Patients not giving their written informed consent;
6. Patients not being able to apply during the study any eye drops product;
7. Patients participating to another clinical study/investigation at the same time as the present investigation or within 30 days;
8. Patients who have history of drug, medication or alcohol abuse or addiction.

Primary outcomes:
measure: Efficacy Assessment of dry eye symptoms from baseline
timeFrame: Day 30
Secondary outcomes:
measure: Efficacy Assessment of dry eye symptoms from baseline
timeFrame: Day 30 and Day 60
measure: Assessment of ocular surface health from baseline
timeFrame: Day 30, Day 60 and Day 90
measure: Efficacy Assesment of drye eye symptoms in visual-related function from baseline
timeFrame: Day 30, Day 60 and Day 90
measure: Efficacy Assessment of patient-subjective evaluation of ocular symptoms from baseline
timeFrame: Day 90
measure: Efficacy Assessment of visual acuity from baseline
timeFrame: Day 90
measure: Assessment of of patients' production of aqueous tears from baseline
timeFrame: Day 30, Day 60 and Day 90
measure: Assessment of Incidence and nature of Adverse Effects
timeFrame: Day 90
Other outcomes:
Locations:
city: Piario
country: Italy
facility: ASST Bergamo Est-Ospedale M.O.A. Locatelli
state: Bergamo
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Biomedico
state: RO
city: Salerno
country: Italy
facility: AOU- San Giovanni di Dio e Ruggi d'Aragona
city: Viterbo
country: Italy
facility: Ospedale Bel Colle
Study officials:
affiliation: AOU-San Giovanni di Dio e Ruggi d'Aragona- Salerno
name: Nicola Rosa, MD
role: PRINCIPAL_INVESTIGATOR
References: