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

NCT06732830 | Completed

• 1 other identifier: DDROPA-PIC01-2021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome

Keywords

Dry eye; DayDrop; Ophtalmic Tears

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

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

  At baseline, in week 4 and in week 12

• Changes in dry eye symptoms through the OSDI scale.

  At baseline, in week 4 and in week 12

• Satisfaction with Treatment.

  At Week 12

• Adverse events.

  Through study completion, apprroximately 12 weeks

Study Arms (1)

DayDrop Advanced

EXPERIMENTAL

Participants will use DayDrop Advanced every day.

Device: DayDrop Advanced ophthalmic drop

Interventions

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.

DayDrop Advanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• i+Med S.Coop.: lead
• Bioaraba Health Research Institute: collaborator

Study Sites (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Álava, 01009, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Quasi-experimental before-after clinical trial.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: December 13, 2024
• Study Start: December 21, 2022
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

ES (1)