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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
ASST Bergamo Est-Ospedale M.O.A. Locatelli
Piario, Bergamo, Italy
RECRUITINGFondazione Policlinico Universitario Campus Biomedico
Roma, RO, Italy
NOT_YET_RECRUITINGAOU- San Giovanni di Dio e Ruggi d'Aragona
Salerno, Italy
RECRUITINGEfficacy 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
Time frame: Day 30
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
Time frame: Day 30 and Day 60
Assessment of ocular surface health from baseline
Change from baseline of the quality of the cornea and the conjunctiva, as measured using the Oxford Grading Scale using the fluorescein staining test. Corneal and conjunctival staining will be conducted using fluorescein instillation into the tear film, and the score will be measured using the Oxford grading scheme. The degree of staining will be based on the number of dots on a series of six panels (A-E). In each panel, fluorescein staining is represented by punctate dots and the staining score will range from 0 to 5 for each panel, for a total possible score ranging from 0 to 15 for the exposed interpalpebral conjunctiva and cornea (Bron et al, 2003). Specifically, the keratoconjunctival staining will be rated mild (stage 0 or 1), moderate (stage 2 or 3), or severe (stage 4 or 5).
Time frame: Day 30, Day 60 and Day 90
Efficacy Assesment of drye eye symptoms in visual-related function from baseline
Change from baseline in computer-vision syndrome questionnaire (CVS-Q) scores. The CVS-Q questionnaire will be used to measure the following symptoms of CVS: eye fatigue, headache, blurred vision, double vision, itching eyes, dryness, tearing, eye redness and pain, excessive blinking, feeling of a foreign body, burning or irritation, difficulty in focusing for near vision, feeling of sight worsening, and sensitivity to light (Gonzalez-Perez et al, 2014). The CVS-Q questionnaire measures the frequency of the above-mentioned symptoms with the response options of "never," "occasionally," and "often or always." If the participants report to have symptoms "occasionally," or "often," they will be asked to rate the intensity of the symptoms, choosing between the options "moderate" or "intense."
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ospedale Bel Colle
Viterbo, Italy
RECRUITINGTime frame: Day 30, Day 60 and Day 90
Efficacy Assessment of patient-subjective evaluation of ocular symptoms from baseline
Change from baseline in Standardized Patient Evaluation of Eye Dryness (SPEED)questionnaire scores. The Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaire gives a score from 0 to 28 that is the result of 8 items that assess frequency and severity of symptoms (Ngo et al, 2013). The symptoms assessed include dryness, grittiness, scratchiness, irritation, burning, watering, soreness, and eye fatigue. The questionnaire assesses whether these symptoms were not problematic (score 0), tolerable (score 1), uncomfortable (score 2), bothersome (score 3), or intolerable (score 4)
Time frame: Day 90
Efficacy Assessment of visual acuity from baseline
Visual function will be assessed by distance visual acuity measurement measured with the Snellen chart, uncorrected distance visual acuity (UDVA, vision with no extraocular optical correction) and best corrected distance visual acuity (BCVA, defined as obtained with the best possible refractive correction). Visual acuity values will be expressed in decimal, fraction or logMAR. All assessments will be performed using standard charts and procedures at specified visual angle, illumination and contrast. Current refraction will be determined prior to visual acuity testing to obtain best-corrected vision.
Time frame: Day 90
Assessment of of patients' production of aqueous tears from baseline
Change from baseline the Schirmer's test I values. The Schirmer's test I is one of the commonly used methods to assess the aqueous tear production. A paper strip is inserted into the eye, under the eyelid, in the lower fornix near the lateral corner, away from the cornea, for five minutes to measure the production of tears. The wet portion of the strip is measured in millimeters. Values above 10 mm have to be considered normal
Time frame: Day 30, Day 60 and Day 90
Assessment of Incidence and nature of Adverse Effects
Incidence and nature of the Serious Adverse Device Effects (SADEs); Incidence and nature of the Adverse Device Effects (ADEs); Incidence and nature of Investigational Medical Device Deficiencies (IMDDs).
Time frame: Day 90