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

NCT ID: NCT04803240

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Dry Eye

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Thealoz Duo

Non applicable

Intervention Type DEVICE

Other Intervention Names

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sodium hyaluronate and trehalose

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iris Pharma

INDUSTRY

Sponsor Role collaborator

Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio MATEO, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Miguel Servet

Philip BUCKHURST, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Plymouth

Locations

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University of Plymouth

Plymouth, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Mateo-Orobia AJ, Farrant S, Del-Prado-Sanz E, Blasco-Martinez A, Idoipe-Corta M, Lafuente-Ojeda N, Pablo-Julvez LE. A Preservative-Free Combination of Sodium Hyaluronate and Trehalose Improves Dry Eye Signs and Symptoms and Increases Patient Satisfaction in Real-Life Settings: The TEARS Study. Ophthalmol Ther. 2024 Dec;13(12):3123-3134. doi: 10.1007/s40123-024-01044-4. Epub 2024 Oct 21.

Reference Type DERIVED
PMID: 39432158 (View on PubMed)

Other Identifiers

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LT2280-PIV-0718

Identifier Type: -

Identifier Source: org_study_id

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