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NCT04803240 Clinical Trial

Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment

Dry Eye Clinical Trial

Official title:
Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04803240
Other study ID # LT2280-PIV-0718
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date March 30, 2020

Study information
Verified date March 2021
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multi-centre, international, non-interventional, prospective survey

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 information / eligibility
Status Completed
Enrollment 310
Est. completion date March 30, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Related Conditions & MeSH terms

Intervention

Device:
• Thealoz Duo
Non applicable

Locations
Country Name City State
United Kingdom University of Plymouth Plymouth

Sponsors (2)
Lead Sponsor Collaborator
Laboratoires Thea Iris Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary OSDI 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. 84 days
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