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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04803240
Enrollment
310
Registered
2021-03-17
Start date
2019-04-01
Completion date
2020-03-30
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Brief summary

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

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.

Interventions

Non applicable

Sponsors

Iris Pharma
CollaboratorINDUSTRY
Laboratoires Thea
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
OSDI84 daysChange 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026