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| Name | Class |
|---|---|
| Iris Pharma | INDUSTRY |
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Multi-centre, international, non-interventional, prospective survey
To assess after 84 days, on a large scale patient population, the evaluation of ocular surface diseases and the satisfaction of dry eye disease (DED) treatment naïve patients or those who had to switch for tolerance, dissatisfaction or efficacy reasons to Thealoz® Duo.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thealoz Duo | Device | Non applicable |
|
| Measure | Description | Time Frame |
|---|---|---|
| OSDI | Change from baseline for patient symptoms using the ocular surface disease index (OSDI©) questionnaire at Day 84. The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. | 84 days |
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Inclusion Criteria:
Exclusion Criteria:
Use of cyclosporine, lifitegrast, tacrolimus, sirolimus within last 3 months and during the survey
Use of topical ophthalmological treatments (glaucoma, etc…)
Use of lacrimal plugs
Ocular surgery in the last 12 months
Concomitant use of corticosteroids
Concomitant use of autologous serum or any blood derivatives
Severe blepharitis
Severe dry eye associated to
Pregnancy/lactation
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All dry eye patients who require artificial tears or need to change their current artificial tears for any reason (i.e. due to dissatisfaction or low efficacy, etc…)
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| Name | Affiliation | Role |
|---|---|---|
| Antonio MATEO, Dr. | Hospital Miguel Servet | Principal Investigator |
| Philip BUCKHURST, Dr. | University of Plymouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Plymouth | Plymouth | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39432158 | Derived | Mateo-Orobia AJ, Farrant S, Del-Prado-Sanz E, Blasco-Martinez A, Idoipe-Corta M, Lafuente-Ojeda N, Pablo-Julvez LE. A Preservative-Free Combination of Sodium Hyaluronate and Trehalose Improves Dry Eye Signs and Symptoms and Increases Patient Satisfaction in Real-Life Settings: The TEARS Study. Ophthalmol Ther. 2024 Dec;13(12):3123-3134. doi: 10.1007/s40123-024-01044-4. Epub 2024 Oct 21. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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