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| Name | Class |
|---|---|
| Bioaraba Health Research Institute | NETWORK |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DayDrop Advanced | Experimental | Participants will use DayDrop Advanced every day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in dry eye signs through modifications in tear film thickness measured by Optical Coherence Tomography. | Optical Coherence Tomography (OCT) evaluates changes in dry eye signs through changes in the thickness of the tear film, measured in microns. | At baseline, in week 4 and in week 12 |
| Changes in dry eye signs through the tear breakup time measured by TBUT test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Araba | Vitoria-Gasteiz | Álava | 01009 | Spain |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Quasi-experimental before-after clinical trial.
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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. |
| At baseline, in week 4 and in week 12 |
| Changes in dry eye symptoms through the OSDI scale. | 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. | At baseline, in week 4 and in week 12 |
| Satisfaction with Treatment. | 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. | At Week 12 |
| Adverse events. | Evaluating number and severity of adverse events. | Through study completion, apprroximately 12 weeks |