Dry Eye SyndromeNCT06732830
Clinical Trial to Assess the Effectiveness of I+Med's DayDrop Advanced Ophthalmic Drop
A study testing DayDrop Advanced ophthalmic drop in people with Dry Eye Syndrome, run by i+Med S.Coop. at 1 site in Spain.
Trial summary
Clinical trial conducted with the aim of evaluating changes in the signs of dry eye through the change in the amount of tears produced, measured through the Schirmer test. It will be performed in 45 patients diagnosed with mild/moderate dry eye who meet the inclusion/exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- DayDrop Advanced ophthalmic drop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2022to 25 Sep 2023
- 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 of both sexes over 18 years of age.
- Patients diagnosed with mild-moderate dry eye who meet the following characteristics: Schirmer test ≥3 and ≤ 10 mm; BUT test ≥5 and ≤ 10 seconds and OSDI ≥13 and ≤ 33.
- Patients without other ophthalmologic pathologies.
- Have ability to self-administer drops.
- Have ability to understand the Patient Information Sheet.
- Sign the Informed Consent.
Who cannot join
- Patients diagnosed with severe dry eye.
- Ingestion of parasympathomimetic or antipsychotic medications .
- Glaucoma.
- Previous cataract surgery.
- Systemic treatment with corticosteroids or topical treatment with any ophthalmic medication except artificial tears in the week prior to the start of study treatment.
- Ocular infection or clinically significant inflammation.
Show all 11Show fewer
- Ocular surgery in the 3 months prior to the study.
- Sjögren's syndrome.
- Stevens-Johnson syndrome.
- History of allergic conjunctivitis.
- Pregnancy or planned lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial for the Evaluation of I+Med's DayDrop Advanced Ophthalmic Drop in Improving Signs and Symptoms of Mild/Moderate Dry Eye
Clinical trial conducted with the aim of evaluating changes in the signs of dry eye through the change in the amount of tears produced, measured through the Schirmer test. It will be performed in 45 patients diagnosed with mild/moderate dry eye who meet the inclusion/exclusion criteria. Follow-up will be 12 weeks with a maximum of 4 visits.
- Conditions
- Dry Eye Syndrome
- Being tested
- DayDrop Advanced ophthalmic drop
- Keywords
- Dry eye, DayDrop, Ophtalmic Tears
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DayDrop Advanced ophthalmic dropDevice
The patient will administer 1 or 2 drops of DayDrop Advanced in each eye 3 times a day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| DayDrop Advanced | Experimental | Participants will use DayDrop Advanced every day. Receives: Device: DayDrop Advanced ophthalmic drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the intensity of dry eye measured by Schirmer's test.
The Schirmer test measures the amount of tears produced in mm of wetted strip.A greater distance in the Schirmer test implies a higher amount of tears produced and therefore a lower intensity of dry eye.
Measured: At baseline, in week 4 and in week 12
Secondary outcomes (5)
Changes in dry eye signs through modifications in tear film thickness measured by Optical Coherence Tomography.
Optical Coherence Tomography (OCT) evaluates changes in dry eye signs through changes in the thickness of the tear film, measured in microns.
Measured: At baseline, in week 4 and in week 12
Changes in dry eye signs through the tear breakup time measured by TBUT test.
The TBUT test measures the tear break-up time (seconds until the appearance of tear break-up). Normal values are considered to be 10 seconds or more. The values from both eyes will be collected, and an average will be calculated for analysis.
Measured: At baseline, in week 4 and in week 12
Changes in dry eye symptoms through the OSDI scale.
The OSDI scale allows for the assessment of the severity and classification of dry eye. The test results are classified as ≤13 normal, between 13 and 22 mild/moderate, and between 23 and 50 moderate/severe.
Measured: At baseline, in week 4 and in week 12
Satisfaction with Treatment.
Pacient´s satisfaction with the treament as assessed using a brie survey. Possible responses range from not satisfied, indifferent, satisfied, very satisfied, and exceptionally satisfied.
Measured: At Week 12
Adverse events.
Evaluating number and severity of adverse events.
Measured: Through study completion, apprroximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start21 Dec 2022
- Primary completion25 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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
- Model description
- Quasi-experimental before-after clinical trial.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioaraba Health Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732830
- Sponsor's protocol ID
- DDROPA-PIC01-2021
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Evaluation of I+Med's DayDrop Advanced Ophthalmic Drop in Improving Signs and Symptoms of Mild/Moderate Dry Eye
- ClinicalTrials.gov ID
- NCT06732830
- Acronym / sponsor ID
- DDROPA-PIC01-2021
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye, DayDrop, Ophtalmic Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Bioaraba Health Research Institute
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 13 Dec 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.
Clinical trial conducted with the aim of evaluating changes in the signs of dry eye through the change in the amount of tears produced, measured through the Schirmer test. It will be performed in 45 patients diagnosed with mild/moderate dry eye who meet the inclusion/exclusion criteria. Follow-up will be 12 weeks with a maximum of 4 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental before-after clinical trial.
| Arm | Type | Receives |
|---|---|---|
| DayDrop Advanced | Experimental | Device: DayDrop Advanced ophthalmic dropParticipants will use DayDrop Advanced every day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both sexes over 18 years of age.
- Patients diagnosed with mild-moderate dry eye who meet the following characteristics: Schirmer test ≥3 and ≤ 10 mm; BUT test ≥5 and ≤ 10 seconds and OSDI ≥13 and ≤ 33.
- Patients without other ophthalmologic pathologies.
- Have ability to self-administer drops.
- Have ability to understand the Patient Information Sheet.
Key exclusion criteria (11 listed)
- Patients diagnosed with severe dry eye.
- Ingestion of parasympathomimetic or antipsychotic medications .
- Glaucoma.
- Previous cataract surgery.
- Systemic treatment with corticosteroids or topical treatment with any ophthalmic medication except artificial tears in the week prior to the start of study treatment.
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 |
|---|---|---|
| DayDrop Advanced ophthalmic dropThe patient will administer 1 or 2 drops of DayDrop Advanced in each eye 3 times a day for 3 months. | Device | DayDrop Advanced |
Primary outcome
Changes in the intensity of dry eye measured by Schirmer's test.
Time frame: At baseline, in week 4 and in week 12
The Schirmer test measures the amount of tears produced in mm of wetted strip.A greater distance in the Schirmer test implies a higher amount of tears produced and therefore a lower intensity of dry eye.
5 secondary outcomes
Changes in dry eye signs through modifications in tear film thickness measured by Optical Coherence Tomography.
Time frame: At baseline, in week 4 and in week 12
Changes in dry eye signs through the tear breakup time measured by TBUT test.
Time frame: At baseline, in week 4 and in week 12
Changes in dry eye symptoms through the OSDI scale.
Time frame: At baseline, in week 4 and in week 12
Satisfaction with Treatment.
Time frame: At Week 12
Adverse events.
Time frame: Through study completion, apprroximately 12 weeks
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 1 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DayDrop Advanced ophthalmic drop in people with Dry Eye Syndrome, run by i+Med S.Coop. at 1 site in Spain.
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 6 inclusion and 11 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Changes in the intensity of dry eye measured by Schirmer's test. (time frame: At baseline, in week 4 and in week 12). 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 1 Apr 2025.