Assessing the effectiveness of a tear substitute with ST-Lysyal in managing symptoms and eye surface changes in people with dry eye disease

Phase 3

Active, not recruiting

• Conditions: Treatment of dry eye disease; Eye Diseases

• Registration Number: ISRCTN13587929
• Lead Sponsor: Ospedale L. Sacco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-09
• Last Update Posted: 22 May 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms are measured using SANDE questionnaire at baseline, 4 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
1.Corneal fluorescein staining (score 0-15) measured after instilling fluorescein on the ocular surface at baseline, 4 and 12 weeks<br>2. Tear break-up time (seconds) measured after instilling fluorescein on the ocular surface at baseline, 4 and 12 weeks