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Completed

NCT Number: NCT06732830

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

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Araba

Vitoria-Gasteiz, Álava, 01009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DayDrop Advanced ophthalmic drop

Device

The patient will administer 1 or 2 drops of DayDrop Advanced in each eye 3 times a day for 3 months.

Primary outcomes

  1. Changes in the intensity of dry eye measured by Schirmer's test.

    Time frame: 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 outcomes

  1. Changes in dry eye signs through modifications in tear film thickness measured by Optical Coherence Tomography.

    Time frame: 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.

  2. Changes in dry eye signs through the tear breakup time measured by TBUT test.

    Time frame: 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.

  3. Changes in dry eye symptoms through the OSDI scale.

    Time frame: 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.

  4. Satisfaction with Treatment.

    Time frame: 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.

  5. Adverse events.

    Time frame: Through study completion, apprroximately 12 weeks

    Evaluating number and severity of adverse events.

Sponsors and collaborators

Lead sponsor

i+Med S.Coop.

Industry

Collaborators

  • Bioaraba Health Research Institute

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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