Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population.
Topically administered lubricants are the basis for treatment of this disease. Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Patients with dry eye syndrome 1 | Experimental | 20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2 |
|
| Experimental: Patients with dry eye syndrome 2 | Experimental | 20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thealoz Duo eye drops and Thealoz Duo gel | Device | Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day (patient diary) | Number of drops of Thealoz Duo® eye drops and Thealoz Duo® gel instilled during the day during the observation period of one week for each medical device (patient diary) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break Up Time (BUT) | 4 weeks | |
| Schirmer I test | 4 weeks | |
| Conjunctival and corneal staining |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30155282 | Derived | Fondi K, Wozniak PA, Schmidl D, Bata AM, Witkowska KJ, Popa-Cherecheanu A, Schmetterer L, Garhofer G. Effect of Hyaluronic Acid/Trehalose in Two Different Formulations on Signs and Symptoms in Patients with Moderate to Severe Dry Eye Disease. J Ophthalmol. 2018 Aug 1;2018:4691417. doi: 10.1155/2018/4691417. eCollection 2018. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Thealoz Duo gel | Device | Thealoz Duo gel during the day and at night for 7 days |
|
|
| 4 weeks |
| OSDI questionnaire | 4 weeks |
| Quality of life of patients (VAS) | 4 weeks |