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Completed

NCT Number: NCT06731725

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Araba

Vitoria-Gasteiz, Álava, 01009, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DayDrop®

Device

The patient will administer 1 to 2 instillations each time it is necessary (at least 2 times a day) and will record it in their data collection notebook.

Primary outcomes

  1. Change in the score obtained in the OSDI questionnaire.

    Time frame: 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 outcomes

  1. Change in the score obtained in the OSDI questionnaire at week 1.

    Time frame: 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.

  2. Assessment by the investigators of the treatment's effectiveness.

    Time frame: 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."

  3. Evaluation by the subjects of the treatment's effectiveness.

    Time frame: 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).

  4. Adverse events.

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

i+Med S.Coop.

Industry

Collaborators

  • Bioaraba Health Research Institute

Registry information

Official study title

Post-marketing Study to Evaluate the Efficacy of I+MED's DayDrop in Improving Mild/Moderate Dry Eye Symptoms

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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