Dry EyeNCT04803240
Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment
An observational study of Dry Eye, run by Laboratoires Thea at 1 site in United Kingdom.
Trial summary
Multi-centre, international, non-interventional, prospective survey Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Thealoz Duo
- Type of treatment
- Medical device
- How many people
- 310 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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…)
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- Severe blepharitis
- Severe dry eye associated to
- Eyelid malposition
- Corneal dystrophy
- Ocular neoplasia
- Sjogren syndrome
- Any systemic pathologies
- Pregnancy/lactation
Trial locations and contacts
1 site in 1 country.
About this study
Multi-centre, international, non-interventional, prospective survey
Read the 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.
- Conditions
- Dry Eye
- Being tested
- Thealoz Duo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thealoz DuoDevice
Also called sodium hyaluronate and trehalose
Non applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI
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.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Apr 2019
- Primary completion30 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iris Pharma
- Responsible party
- Sponsor
- Investigators
- Antonio MATEO, Dr., Principal investigator, Hospital Miguel ServetPhilip BUCKHURST, Dr., Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803240
- Sponsor's protocol ID
- LT2280-PIV-0718
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39432158
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment
- ClinicalTrials.gov ID
- NCT04803240
- Acronym / sponsor ID
- LT2280-PIV-0718
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Collaborators
- Iris Pharma
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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…)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thealoz DuoAlso: sodium hyaluronate and trehaloseNon applicable | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 39432158Mateo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio MATEO, Dr. principal investigator
Hospital Miguel Servet
Philip BUCKHURST, Dr. principal investigator
University of Plymouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Laboratoires Thea at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.