Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment
- Conditions
- Dry Eye
- Registration Number
- NCT04803240
- Lead Sponsor
- Laboratoires Thea
- Brief Summary
Multi-centre, international, non-interventional, prospective survey
- Detailed Description
To assess after 84 days, on a large scale patient population, the evaluation of ocular surface diseases and the satisfaction of dry eye disease (DED) treatment naïve patients or those who had to switch for tolerance, dissatisfaction or efficacy reasons to Thealoz® Duo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
- All dry eye patients who require artificial tears or need to change their current artificial tears for any reason (i.e. due to dissatisfaction or low efficacy, etc...)
- Outpatients of either sex, aged at least 18 years
- Patients informed of the objectives of the survey and agreeing to participate.
-
Use of cyclosporine, lifitegrast, tacrolimus, sirolimus within last 3 months and during the survey
-
Use of topical ophthalmological treatments (glaucoma, etc...)
-
Use of lacrimal plugs
-
Ocular surgery in the last 12 months
-
Concomitant use of corticosteroids
-
Concomitant use of autologous serum or any blood derivatives
-
Severe blepharitis
-
Severe dry eye associated to
- Eyelid malposition
- Corneal dystrophy
- Ocular neoplasia
- Sjogren syndrome
- Any systemic pathologies
-
Pregnancy/lactation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OSDI 84 days Change from baseline for patient symptoms using the ocular surface disease index (OSDI©) questionnaire at Day 84. The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Plymouth
🇬🇧Plymouth, United Kingdom