Clincosm LogoSign in Get a demo

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

Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT04803240
Collaborator
Iris Pharma (Industry)
310
Enrollment
1
Location
12
Actual Duration (Months)
25.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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

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 :
Apr 1, 2019
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Mar 30, 2020

Outcome Measures

Primary Outcome Measures

  1. OSDI [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 University of Plymouth Plymouth United Kingdom

Sponsors and Collaborators

  • Laboratoires Thea
  • Iris Pharma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT04803240
Other Study ID Numbers:
  • LT2280-PIV-0718
First Posted:
Mar 17, 2021
Last Update Posted:
Mar 17, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dry Eye Syndromes
Hyaluronic Acid

Study Results

No Results Posted as of Mar 17, 2021