Hospital Universitario Araba
Vitoria-Gasteiz, Álava, 01009, Spain
NCT Number: NCT06731725
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Vitoria-Gasteiz, Álava, 01009, Spain
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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."
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).
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%.
i+Med S.Coop.
Industry
Post-marketing Study to Evaluate the Efficacy of I+MED's DayDrop in Improving Mild/Moderate Dry Eye Symptoms
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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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