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

NCT ID: NCT06732830

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-21
• Study Completion Date: 2023-09-25

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

Study Design

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

Study Groups

DayDrop Advanced

Participants will use DayDrop Advanced every day.

Group Type: EXPERIMENTAL

DayDrop Advanced ophthalmic drop

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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

DDROPA-PIC01-2021

Identifier Type: -

Identifier Source: org_study_id