Post-marketing Study Focused on Evaluating I+Med's DayDrop for Improving Signs and Symptoms of Mild/Moderate Dry Eye

Not Applicable

Completed

• Conditions: Dry Eye; Dry Eye Syndrome (DES)

• Registration Number: NCT06731725
• Lead Sponsor: i+Med S.Coop.

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).

Study Timeline

• Study Start: 2021-02-17
• Primary Completion: 2021-03-31
• Study Completion: 2022-02-23
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in the score obtained in the OSDI questionnaire.	At baseline and in week 3	The OSDI questionnaire will be completed by the patients and is used to analyze the presence of progress in dry eye symptoms. The 12 questions of the OSDI questionnaire will be used to calculate the index (total score range from 0 to 48). The score obtained for these parameters at the start of the study (baseline) will be compared with the score obtained at the end of the follow-up period.; To support the hypothesis of effectiveness, treatment with DayDrop will result in a significant improvement (of at least 6 points out of 48) in the OSDI index scores at the end of the follow-up period, compared to the values recorded at the start of the study.

Secondary Outcome Measures

Name	Time	Method
Change in the score obtained in the OSDI questionnaire at week 1.	At week 1	he 12 questions of the OSDI questionnaire will be used to calculate the index (total score range from 0 to 48). The score obtained for these parameters at the start of the study (baseline) will be compared with the score obtained at the end of the follow-up period.; To support the hypothesis of effectiveness, treatment with DayDrop will result in a significant improvement (of at least 6 points out of 48) in the OSDI index scores at the end of the follow-up period, compared to the values recorded at the start of the study.
Assessment by the investigators of the treatment's effectiveness.	At week 2	A questionnaire for the final evaluation of the treatment will be provided to the investigator. A questionnaire for the final evaluation of the treatment will be provided to the investigator. A response rate will be calculated, which should be at least 50% of responders, defined as those cases rated as "Improvement," "Significant Improvement," or "Exceptional Improvement."
Evaluation by the subjects of the treatment's effectiveness.	At week 2	A questionnaire for the final evaluation of the treatment will be provided to the patients. In an exploratory manner, global improvement in terms of the frequency and severity of symptoms will be assessed at the end of the treatment. A satisfaction rating of "Satisfied," "Very Satisfied," or "Exceptionally Satisfied" is expected in at least 50% of the cases. Additionally, the duration of the effect and the number of times drops were needed will be evaluated in comparison to other eye drops previously used (≥ 50% of patients rating the effect as at least as long-lasting and using the same or fewer daily drops compared to other eye drops used previously).
Adverse events.	Through study completion, apprroximately 3 weeks	Evaluating number and severity of adverse events through the systematic recording and analysis of the events and incidents detected during the study. The incidence of incidents with DayDrop should be significantly low and should not exceed the threshold set at 1%.

Trial Locations

Locations (1)

Hospital Universitario Araba; 🇪🇸 Vitoria-Gasteiz, Álava, Spain