Clinical trial NCT06731725: Post-marketing Study Focused on Evaluating I+Med's DayDrop for Improving Signs and Symptoms of Mild/Moderate Dry Eye
Official title: Post-marketing Study to Evaluate the Efficacy of I+MED's DayDrop in Improving Mild/Moderate Dry Eye Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Dry Eye Syndrome (DES)
Keywords: Dry eye
DayDrop
Opthalmic Tears
Lead sponsor: i+Med S.Coop.
Sponsor class: INDUSTRY
Collaborators: name: Bioaraba Health Research Institute
First posted: 2024-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical post-marketing quasi-experimental before-and-after trial, which includes 20 patients diagnosed with mild/moderate dry eye disease (defined by a score on the OSDI test ≥13 and ≤22) who attend the ophthalmology consultation at the outpatient building of the Araba University Hospital and meet the inclusion criteria with no exclusion criteria.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Clinical post-marketing quasi-experimental before-and-after trial to determine the effectiveness of DayDrop treatment in subjects seeking relief from the signs of dryness and eye irritation, comparing the scores obtained at the end of the follow-up period with those established before the start of treatment (baseline condition), as measured by the patients according to the OSDI questionnaire.

The study will involve 20 patients diagnosed with mild/moderate dry eye disease who meet the inclusion/exclusion criteria of the protocol. The study duration will be 2 weeks, including 3 visits: baseline, visit 1 (after one week of treatment), and visit 2 (at 2 weeks from the start of treatment).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the score obtained in the OSDI questionnaire.
timeFrame: At baseline and in week 3
Secondary outcomes:
measure: Change in the score obtained in the OSDI questionnaire at week 1.
timeFrame: At week 1
measure: Assessment by the investigators of the treatment's effectiveness.
timeFrame: At week 2
measure: Evaluation by the subjects of the treatment's effectiveness.
timeFrame: At week 2
measure: Adverse events.
timeFrame: Through study completion, apprroximately 3 weeks
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario Araba
state: Álava
Study officials:
References: