Evaluation of symptoms and signs of evaporative dry eye with a lipid-enhanced artificial tear drop
Phase 4
Completed
- Conditions
- Evaporative dry eyeEye Diseases
- Registration Number
- ISRCTN10208997
- Lead Sponsor
- Centro de la Vision
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1. 18 and 50 years
2. Symptomatic dry-eye disease, according to (Dry eye workshop II) DEWS II criteria
Exclusion Criteria
1. Contact lens wearers
2. Previous ocular surgery
3. History of major systemic or ocular conditions
4. Active ocular inflammation or inflammatory and autoimmune conditions (I.E. ocular cicatricial pemphigoid, Sjögren’s disease)
5. Glaucoma medications or other concomitant use of drops
6. Schirmer’s test <10 mm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dry eye symptoms (Ocular surface disease index questionnaire; OSDI) at baseline, 1 month, and 3 months
- Secondary Outcome Measures
Name Time Method 1. Tear break-up time and corneal staining (National Eye Institute scale) were assessed at baseline and at 3 months<br>2. Osmolarity (measured in mosm/L) was evaluated at baseline and at 3 months using the TearLab Osmometer<br>3. Lipid layer thickness (categorized as normal/mild/moderate/severe), non-invasive tear break-up time (measured in seconds), and tear meniscus were assessed at baseline and at 3 months using the Keratograph 5M device