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The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed to controlled adverse environmental conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thealoz | Experimental | Treatment with Thealoz (Trehalose) 3% for 1 month |
|
| Treatment with Thealoz“s vehicle | Placebo Comparator | Treatment with Thealoz“s vehicle for 1 month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thealoz | Other | Instillation of 1 drop of Thealoz |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with fluorescein corneal staining reduction of at least 1 point | Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group | 1 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | Best Corrected Visual Acuity at Exit visit compared to baseline visit | 1 month |
| Intraocular pressure | Pathological elevations of intraocular pressure from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Jesus Gonzalez, PhD | IOBA - University of Valladolid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IOBA - University of Valladolid | Valladolid | Valladolid | 47011 | Spain |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014199 | Trehalose |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
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| Vehicle | Other | 1 drop of the vehicle will be instillated in the eye |
|
|
| 1 month |
| Eye fundus alterations | Presence of any pathological finding in eye fundus while the patient is in the study | 1 month |
| Corneal Pachymetry | Changes in corneal thickness along the study | 1 month |
| D009844 |
| Oligosaccharides |
| D000073893 | Sugars |