Clinical Trial to Assess the Effectiveness of I+Med's DayDrop Advanced Ophthalmic Drop

Clinical Trial for the Evaluation of I+Med's DayDrop Advanced Ophthalmic Drop in Improving Signs and Symptoms of Mild/Moderate Dry Eye

Clinical trial conducted with the aim of evaluating changes in the signs of dry eye through the change in the amount of tears produced, measured through the Schirmer test. It will be performed in 45 patients diagnosed with mild/moderate dry eye who meet the inclusion/exclusion criteria. Follow-up will be 12 weeks with a maximum of 4 visits.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Device: DayDrop Advanced ophthalmic drop

Detailed Description

Historically, dry eye disease (DED) has been considered largely due to tear insufficiency and has been treated by prescribing tear substitutes. The replacement of tears with ocular lubricants has traditionally been considered a cornerstone of DED treatment, and there are numerous topical formulas available.

In this regard, DayDrop Advanced introduces as an innovation the inclusion of gamma poly(glutamic acid) (γ-PGA) in its composition.

The product under investigation, DayDrop Advanced, is a sterile ocular lubricant drop based on γ-PGA and hyaluronic acid. It is a biocompatible solution, phosphate-free, preservative-free, and compatible with contact lenses. It has suitable mechanical properties that stabilize and protect the ocular surface while maintaining a moist local environment. Due to its components' high water retention capacity and viscosity, this ophthalmic drop helps clean, hydrate, and lubricate the ocular surface. It supplements the tear film, relieving pain, dryness, and eye irritation.

This clinical research is part of the product development and forms the basis for obtaining its certification, aiming to demonstrate both the safety and effectiveness of the product. The preparation and execution of the protocol or research plan have taken into account the recommendations of TFOS DEWS II and followed the guidelines of good clinical practice ICH-GCP E6 (R2) , as well as the recommendations of the principal investigator of the study.

It consists of a quasi-experimental before-and-after clinical trial in patients diagnosed with mild/moderate dry eye. Mild/moderate dry eye is defined as a condition that produces symptoms in the patient and may or may not have detectable signs under the slit lamp, but which can disappear with appropriate treatment.

• Study Type: Interventional
• Enrollment (Actual): 45
• 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 diagnosed with mild-moderate dry eye who meet the following characteristics: Schirmer test ≥3 and ≤ 10 mm; BUT test ≥5 and ≤ 10 seconds and OSDI ≥13 and ≤ 33.
• Patients without other ophthalmologic pathologies.
• Have ability to self-administer drops.
• Have ability to understand the Patient Information Sheet.
• Sign the Informed Consent.

Exclusion Criteria:

• Patients diagnosed with severe dry eye.
• Ingestion of parasympathomimetic or antipsychotic medications .
• Glaucoma.
• Previous cataract surgery.
• Systemic treatment with corticosteroids or topical treatment with any ophthalmic medication except artificial tears in the week prior to the start of study treatment.
• Ocular infection or clinically significant inflammation.
• Ocular surgery in the 3 months prior to the study.
• Sjögren's syndrome.
• Stevens-Johnson syndrome.
• History of allergic conjunctivitis.
• Pregnancy or planned lactation.

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 Advanced; Participants will use DayDrop Advanced every day.	Device: DayDrop Advanced ophthalmic drop; The patient will administer 1 or 2 drops of DayDrop Advanced in each eye 3 times a day for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the intensity of dry eye measured by Schirmer's test.	The Schirmer test measures the amount of tears produced in mm of wetted strip.A greater distance in the Schirmer test implies a higher amount of tears produced and therefore a lower intensity of dry eye.	At baseline, in week 4 and in week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in dry eye signs through modifications in tear film thickness measured by Optical Coherence Tomography.	Optical Coherence Tomography (OCT) evaluates changes in dry eye signs through changes in the thickness of the tear film, measured in microns.	At baseline, in week 4 and in week 12
Satisfaction with Treatment.	Pacient´s satisfaction with the treament as assessed using a brie survey. Possible responses range from not satisfied, indifferent, satisfied, very satisfied, and exceptionally satisfied.	At Week 12
Adverse events.	Evaluating number and severity of adverse events.	Through study completion, apprroximately 12 weeks
Changes in dry eye signs through the tear breakup time measured by TBUT test.	The TBUT test measures the tear break-up time (seconds until the appearance of tear break-up). Normal values are considered to be 10 seconds or more. The values from both eyes will be collected, and an average will be calculated for analysis.	At baseline, in week 4 and in week 12
Changes in dry eye symptoms through the OSDI scale.	The OSDI scale allows for the assessment of the severity and classification of dry eye. The test results are classified as ≤13 normal, between 13 and 22 mild/moderate, and between 23 and 50 moderate/severe.	At baseline, in week 4 and in week 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Dry eye; DayDrop; Ophtalmic Tears
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: DDROPA-PIC01-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No