Status:
UNKNOWN
Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease
Lead Sponsor:
Fidia Farmaceutici s.p.a.
Conditions:
Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
Eligibility:
All Genders
18+ years
Phase:
NA
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 acco...
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 du...
Eligibility Criteria
Inclusion
- 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;
- 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
- 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.
Key Trial Info
Start Date :
February 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06190054
Start Date
February 6 2023
End Date
December 1 2024
Last Update
June 12 2024
Active Locations (4)
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1
ASST Bergamo Est-Ospedale M.O.A. Locatelli
Piario, Bergamo, Italy, 24020
2
Fondazione Policlinico Universitario Campus Biomedico
Roma, RO, Italy, 00128
3
AOU- San Giovanni di Dio e Ruggi d'Aragona
Salerno, Italy, 84131
4
Ospedale Bel Colle
Viterbo, Italy, 01100