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

March 16, 2021 updated by: Laboratoires Thea
Multi-centre, international, non-interventional, prospective survey

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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…)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI
Time Frame: 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.
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Collaborators

Iris Pharma

Investigators

  • Principal Investigator: Antonio MATEO, Dr., Hospital Miguel Servet
  • Principal Investigator: Philip BUCKHURST, Dr., University of Plymouth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (ACTUAL)

March 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2280-PIV-0718

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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