Post-marketing Study Focused on Evaluating I+Med's DayDrop for Improving Signs and Symptoms of Mi… (NCT06731725) | Clinical Trial Compass
CompletedNot Applicable
Post-marketing Study Focused on Evaluating I+Med's DayDrop for Improving Signs and Symptoms of Mild/Moderate Dry Eye
Spain20 participantsStarted 2021-02-17
Plain-language summary
Clinical post-marketing quasi-experimental before-and-after trial to determine the effectiveness of DayDrop treatment in subjects seeking relief from symptoms of dryness and eye irritation based on OSDI questionnaire scores completed by patients.The study will involve 20 patients diagnosed with mild/moderate dry eye disease who meet the inclusion/exclusion criteria. The duration of the study will be 2 weeks, including 3 visits.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of both sexes over 18 years of age.
* Patients presenting symptoms of dryness and ocular irritation with an OSDI score ≥13 and ≤22.
* Ability to self-administer the drops.
* Ability to understand the Patient Information Sheet and sign the Informed Consent.
* Willingness and sufficient ability, as judged by the investigator, to respond to the questionnaires included in the study.
Exclusion Criteria:
* Pregnant women or those in the breastfeeding period.
* Known allergy or hypersensitivity to hyaluronic acid or any other ingredient in the product being studied.
* Patients who have undergone previous ocular surgery or experienced ocular trauma in the year prior to the start of the study.
* Severe dry eye diagnosis.
* Presence of inflammatory ocular surface pathology or anterior segment disease, or diagnosed with glaucoma.
* Use of parasympathomimetic or antipsychotic medications.
* Previous cataract surgery.
* Systemic corticosteroid treatment or topical treatment with any ophthalmic medication, except artificial tears, in the week before the start of the study.
* Sjögren's syndrome.
* Stevens-Johnson syndrome.
* History of allergic conjunctivitis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has already been completed — does that mean results are available, and if so, what did the OSDI questionnaire scores show about whether DayDrop actually improved dry eye symptoms?
2Since this was a post-marketing study rather than a traditional clinical trial phase, what does that mean for how well-established the safety and effectiveness of DayDrop already is compared to other eye drops I might consider?
3The study focused on mild to moderate dry eye — given my specific diagnosis and severity, do you think my symptoms fall within that range, and would DayDrop be a reasonable option to try?
4Are there standard dry eye treatments or prescription options you'd recommend I try first before considering a newer product like DayDrop, especially since this study only tracked OSDI questionnaire scores and not longer-term outcomes?
5Would using DayDrop interfere with any other eye medications or treatments I'm currently using, and is there anything about my eye health history that would make it a better or worse fit than other artificial tear options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the score obtained in the OSDI questionnaire.