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

Not Applicable

Completed

• Conditions: Dry Eye Syndrome

• Registration Number: NCT06732830
• Lead Sponsor: i+Med S.Coop.

Brief Summary

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.

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 Timeline

• Study Start: 2022-12-21
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in the intensity of dry eye measured by Schirmer's test.	At baseline, in week 4 and in week 12	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.

Secondary Outcome Measures

Name	Time	Method
Changes in dry eye signs through modifications in tear film thickness measured by Optical Coherence Tomography.	At baseline, in week 4 and in week 12	Optical Coherence Tomography (OCT) evaluates changes in dry eye signs through changes in the thickness of the tear film, measured in microns.
Changes in dry eye signs through the tear breakup time measured by TBUT test.	At baseline, in week 4 and in week 12	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.
Changes in dry eye symptoms through the OSDI scale.	At baseline, in week 4 and in week 12	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.
Satisfaction with Treatment.	At Week 12	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.
Adverse events.	Through study completion, apprroximately 12 weeks	Evaluating number and severity of adverse events.

Trial Locations

Locations (1)

Hospital Universitario Araba; 🇪🇸 Vitoria-Gasteiz, Álava, Spain