Treatment of dry eye disease Eye Diseases
Conditions
Interventions
Patients will be divided into two groups and treatments will be assigned following a randomization list. The study group will use Relys eye drops and the control group Xiloial Zero.
The randomisation
Sponsors
Ospedale L. Sacco
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes affected by dry eye disease with persistent/intermittent symptoms for at least 6 months 2. SANDE questionnaire score at baseline = 30 and simultaneous positivity to at least one of the following parameters: 3. Corneal fluorescein staining score = 2 (NEI National eye Institute grading scale) 4. Average T-BUT (Tear Film Break up Time) = 10 seconds 5. Ability to provide written informed consent and follow study procedures 6. Women of childbearing potential who are negative for a pregnancy test
Exclusion criteria
Exclusion criteria: 1. Patients in systemic and/or local therapy with products with anti-inflammatory activity 2. Patients with other ocular surface pathologies in progress 3. Surgical or parasurgical interventions in the study eye within 3 months prior to the start of treatment 4. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms are measured using SANDE questionnaire at baseline, 4 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Corneal fluorescein staining (score 0-15) measured after instilling fluorescein on the ocular surface at baseline, 4 and 12 weeks 2. Tear break-up time (seconds) measured after instilling fluorescein on the ocular surface at baseline, 4 and 12 weeks | — |
Countries
Italy
Outcome results
None listed