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

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ClinicalTrials.gov Identifier: NCT04803240
Recruitment Status : Completed
First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
Iris Pharma
Information provided by (Responsible Party):
Laboratoires Thea

Study Description
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Brief Summary:
Multi-centre, international, non-interventional, prospective survey

Condition or disease Intervention/treatment
Dry Eye Device: Thealoz Duo

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 Design
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Study Type : Observational
Actual Enrollment : 310 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : March 30, 2020
Groups and Cohorts
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Intervention Details:
  • Device: Thealoz Duo
    Non applicable
    Other Name: sodium hyaluronate and trehalose

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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…)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803240


Locations
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United Kingdom
University of Plymouth
Plymouth, United Kingdom
Sponsors and Collaborators
Laboratoires Thea
Iris Pharma
Investigators
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Principal Investigator: Antonio MATEO, Dr. Hospital Miguel Servet
Principal Investigator: Philip BUCKHURST, Dr. University of Plymouth
More Information
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Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT04803240    
Other Study ID Numbers: LT2280-PIV-0718
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents