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

i+Med S.Coop.

Status

Completed

Conditions

Dry Eye Syndrome

Treatments

Device: DayDrop Advanced ophthalmic drop

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT06732830

DDROPA-PIC01-2021

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.