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OpenTrials
Completed

NCT Number: NCT04803240

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Plymouth

Plymouth, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thealoz Duo

Device

Non applicable

Other names: sodium hyaluronate and trehalose

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Collaborators

  • Iris Pharma

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 17, 2021
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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