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

i+Med S.Coop.

Status: Completed

Conditions: Dry Eye Syndrome (DES); Dry Eye

Treatments: Device: DayDrop®

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT06731725

DayDrop-PIC01-2020

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

DayDrop®

Experimental group

Description:

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.

Treatment:

Device: DayDrop®