Dry Eye Syndrome
Conditions
Keywords
Dry eye, DayDrop, Ophtalmic Tears
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.
Interventions
DEVICEDayDrop Advanced ophthalmic drop
The patient will administer 1 or 2 drops of DayDrop Advanced in each eye 3 times a day for 3 months.
Sponsors
Bioaraba Health Research Institute
i+Med S.Coop.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Quasi-experimental before-after clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed