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

NCT06731725 | Completed

• 1 other identifier: DayDrop-PIC01-2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Dry Eye Syndrome (DES)

Keywords

Dry eye; DayDrop; Opthalmic Tears

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  At week 1

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

  At week 2

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

  At week 2

• Adverse events.

  Through study completion, apprroximately 3 weeks

Study Arms (1)

DayDrop®

EXPERIMENTAL

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®

Interventions

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.

DayDrop®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• i+Med S.Coop.: lead
• Bioaraba Health Research Institute: collaborator

Study Sites (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Álava, 01009, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 12, 2024
• Study Start: February 17, 2021
• Primary Completion: March 31, 2021
• Study Completion: February 23, 2022
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

ES (1)