Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal UsersNCT06190054
Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease
A study testing MERAMIRT in people with Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users, run by Fidia Farmaceutici s.p.a. at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
- What is being tested?
- MERAMIRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesItaly
- Study dates
- 6 Feb 2023to 4 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
ASST Bergamo Est-Ospedale M.O.A. Locatelli
Piario, Bergamo, 24020
Fondazione Policlinico Universitario Campus Biomedico
Roma, RO, 00128
AOU- San Giovanni di Dio e Ruggi d'Aragona
Salerno, Salerno, 84131
Ospedale Bel Colle
Viterbo, Viterbo, 01100
About this study
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
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.
Read the 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.
- Conditions
- Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
- Being tested
- MERAMIRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MERAMIRTDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MERAMIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 30
Secondary outcomes (7)
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
Measured: Day 60 and Day 90
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).
Measured: 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."
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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).
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start6 Feb 2023
- Primary completion3 Jan 2025
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal UsersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola Rosa, MD, Principal investigator, AOU-San Giovanni di Dio e Ruggi d'Aragona- Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190054
- Sponsor's protocol ID
- IS44-21-01
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06190054
- Acronym / sponsor ID
- IS44-21-01
- Conditions
- Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MERAMIRT | Experimental | Device: MERAMIRTPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MERAMIRTMERAMIRT®, 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 | Device | MERAMIRT |
Primary outcome
Efficacy Assessment of dry eye symptoms from baseline
Time frame: Day 30
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
7 secondary outcomes
Efficacy Assessment of dry eye symptoms from baseline
Time frame: Day 60 and Day 90
Assessment of ocular surface health from baseline
Time frame: Day 30, Day 60 and Day 90
Efficacy Assesment of drye eye symptoms in visual-related function from baseline
Time frame: Day 30, Day 60 and Day 90
Efficacy Assessment of patient-subjective evaluation of ocular symptoms from baseline
Time frame: Day 90
Efficacy Assessment of visual acuity from baseline
Time frame: Day 90
Assessment of of patients' production of aqueous tears from baseline
Time frame: Day 30, Day 60 and Day 90
Assessment of Incidence and nature of Adverse Effects
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Rosa, MD principal investigator
AOU-San Giovanni di Dio e Ruggi d'Aragona- Salerno
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MERAMIRT in people with Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users, run by Fidia Farmaceutici s.p.a. at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Assessment of dry eye symptoms from baseline (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.