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

NCT ID: NCT06731725

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2022-02-23

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.

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).

Conditions

Dry Eye; Dry Eye Syndrome (DES)

Keywords

Dry eye; DayDrop; Opthalmic Tears

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

DayDrop®

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioaraba Health Research Institute

NETWORK

Sponsor Role: collaborator

i+Med S.Coop.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Araba

Vitoria-Gasteiz, Álava, Spain

Countries

Spain

Other Identifiers

DayDrop-PIC01-2020

Identifier Type: -

Identifier Source: org_study_id