CompletedNot Applicable

Clinical Trial to Assess the Effectiveness of I+Med's DayDrop Advanced Ophthalmic Drop

Spain45 participantsStarted 2022-12-21

Plain-language 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. Follow-up will be 12 weeks with a maximum of 4 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 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. Exclusion Criteria: * 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. * Ocular surgery in the 3 months prior to the study. * Sjögren's syndrome. * Stevens-Johnson syndrome. * History of allergic conjunctivitis. * Pregnancy or planned lactation.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Changes in the intensity of dry eye measured by Schirmer's test.

Timeframe: At baseline, in week 4 and in week 12

Trial details

NCT IDNCT06732830

Sponsori+Med S.Coop.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-25

View on ClinicalTrials.gov More Dry Eye Syndrome trials