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 range18 Years
SexALL
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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.
What they're measuring
1
Change in the score obtained in the OSDI questionnaire.