Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment
1 other identifier
observational
310
1 country
1
Brief Summary
Multi-centre, international, non-interventional, prospective survey
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedFirst Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedMarch 17, 2021
March 1, 2021
9 months
February 25, 2021
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility 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…)
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laboratoires Thealead
- Iris Pharmacollaborator
Study Sites (1)
University of Plymouth
Plymouth, United Kingdom
Related Publications (1)
Mateo-Orobia AJ, Farrant S, Del-Prado-Sanz E, Blasco-Martinez A, Idoipe-Corta M, Lafuente-Ojeda N, Pablo-Julvez LE. A Preservative-Free Combination of Sodium Hyaluronate and Trehalose Improves Dry Eye Signs and Symptoms and Increases Patient Satisfaction in Real-Life Settings: The TEARS Study. Ophthalmol Ther. 2024 Dec;13(12):3123-3134. doi: 10.1007/s40123-024-01044-4. Epub 2024 Oct 21.
PMID: 39432158DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio MATEO, Dr.
Hospital Miguel Servet
- PRINCIPAL INVESTIGATOR
Philip BUCKHURST, Dr.
University of Plymouth
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 17, 2021
Study Start
April 1, 2019
Primary Completion
December 30, 2019
Study Completion
March 30, 2020
Last Updated
March 17, 2021
Record last verified: 2021-03