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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye Syndrome (DES)
• Intervention / Treatment: Device: DayDrop®

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Álava
    • Vitoria-Gasteiz, Álava, Spain, 01009
      • Hospital Universitario Araba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DayDrop®; Medical Device IIa class. DayDrop is a biocompatible ophthalmic solution indicated to relieve dryness and ocular irritation. DayDrop is composed of ectoine, carboxymethylcellulose, and sodium hyaluronate. The product is obtained by dissolving the components in a borate buffer (pH = 7.2-7.6) prepared with boric acid and sodium tetraborate. The manufacturing and packaging of the product are carried out under aseptic processing conditions following the UNE-EN ISO 13408:2015 standard, and the product is sterilized through sterilizing filtration. DayDrop is defined as a sterile product, buffered to a neutral pH, phosphate-free, preservative-free, and compatible with contact lenses according to ISO 11981.

Device: DayDrop®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the score obtained in the OSDI questionnaire.	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.	At baseline and in week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the score obtained in the OSDI questionnaire 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.	At week 1
Assessment by the investigators of the treatment's effectiveness.	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."	At week 2
Evaluation by the subjects of the treatment's effectiveness.	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).	At week 2
Adverse events.	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%.	Through study completion, apprroximately 3 weeks

Collaborators and Investigators

• Sponsor: i+Med S.Coop.
• Collaborators: Bioaraba Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Dry eye; DayDrop; Opthalmic Tears
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: DayDrop-PIC01-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No