Dry Eye SyndromesEMO-01NCT06499753
Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use
An observational study of Dry Eye Syndromes and Hyaluronic Acid, run by University of Valladolid at 1 site in Spain.
Trial summary
This study assessed the differences in DED symptomatology measured with the OSDI questionnaire regarding climate data of the geographic location in a large population in Spain, with a special focus on the relative humidity (RH) of the place of residence and the impact of artificial tears use, to help eye care… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Hyaluronic Acid, OSDI
- What is being tested?
- high molecular weight HA-based artificial tears
- How many people
- 1,033 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2020to 31 Jan 2022
- How long will I take part?
- 3 Months
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health volunteers
Who may be able to join
- Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher of each center
Who cannot join
- Hyperthyroidis
- Rheumatism
- Lupus
- Autoimmune disease
- Previous diagnosis of Dye Eye Disease
- Cicatricial conjunctivitis
Show all 12Show fewer
- Pterygium
- Eyelid trichiasis
- History of any eye medication use in the last 3 months to treat any eye condition (glaucoma, etc.)
- Active anterior eye inflammation (such as blepharitis, conjunctivitis, keratitis, scleritis, uveitis, etc.)
- Use of contact lenses in the last 3 months
- Previous ocular trauma or surgery in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
This study assessed the differences in DED symptomatology measured with the OSDI questionnaire regarding climate data of the geographic location in a large population in Spain, with a special focus on the relative humidity (RH) of the place of residence and the impact of artificial tears use, to help eye care practitioners in patient management and education
Read the detailed description
This was a multicentre study enrolling patients to attend primary eye care centres of the EMO research group across 12 different Spanish locations. A comprehensive eye examination was performed in all participants. Dryness symptomatology was assessed with OSDI questionnaire. In subjects with dryness symptomatology (OSDI questionnaire score between 13 and 32) were prescribed to use high molecular weight HA-based artificial tears (DISOP Inc, Spain) along three months), instilled 3 times per day.
Additionally, the daily mean, minimum, and maximum values of the climate data for five different variables [skin temperature (°C), wind gusts (m/s), air temperature (°C), atmospheric pressure (Pa) and RH (%)] corresponding to the visit date were collected from the EU-funded Copernicus Climate Change Service and the 5-year average RH values published by the Spanish meteorological agency.
- Conditions
- Dry Eye Syndromes, Hyaluronic Acid, OSDI
- Being tested
- high molecular weight HA-based artificial tears
- 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.
high molecular weight HA-based artificial tearsOther
use of high molecular weight HA-based artificial tears three times per day
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI Score
Change in the Ocular Surface Disease Index (OSDI) score ranged from 0 (asymptomatic) to 100 (severe dry eye)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Feb 2020
- Primary completion30 Nov 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,033 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Martin Herranz, University of Valladolid
- Investigators
- Raul Martin, PhD, Principal investigator, IOBA Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499753
- Sponsor's protocol ID
- UVaGiO-PI201606
- Acronym
- EMO-01
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available by request to PI
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use
- ClinicalTrials.gov ID
- NCT06499753
- Acronym / sponsor ID
- EMO-01 / UVaGiO-PI201606
- Conditions
- Dry Eye Syndromes, Hyaluronic Acid, OSDI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,033 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 12 Jul 2024 (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.
This study assessed the differences in DED symptomatology measured with the OSDI questionnaire regarding climate data of the geographic location in a large population in Spain, with a special focus on the relative humidity (RH) of the place of residence and the impact of artificial tears use, to help eye care practitioners in patient management and education
Detailed description
This was a multicentre study enrolling patients to attend primary eye care centres of the EMO research group across 12 different Spanish locations. A comprehensive eye examination was performed in all participants. Dryness symptomatology was assessed with OSDI questionnaire. In subjects with dryness symptomatology (OSDI questionnaire score between 13 and 32) were prescribed to use high molecular weight HA-based artificial tears (DISOP Inc, Spain) along three months), instilled 3 times per day.
Additionally, the daily mean, minimum, and maximum values of the climate data for five different variables [skin temperature (°C), wind gusts (m/s), air temperature (°C), atmospheric pressure (Pa) and RH (%)] corresponding to the visit date were collected from the EU-funded Copernicus Climate Change Service and the 5-year average RH values published by the Spanish meteorological agency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health volunteers
Key inclusion criteria (1 listed)
- Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher of each center
Key exclusion criteria (12 listed)
- Hyperthyroidis
- Rheumatism
- Lupus
- Autoimmune disease
- Previous diagnosis of Dye Eye Disease
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 |
|---|---|---|
| high molecular weight HA-based artificial tearsuse of high molecular weight HA-based artificial tears three times per day | Other | – |
Primary outcome
OSDI Score
Time frame: three months
Change in the Ocular Surface Disease Index (OSDI) score ranged from 0 (asymptomatic) to 100 (severe dry eye)
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 Jul 2024.
- Individual participant dataSharing planned: No. Data will be available by request to PI
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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.
Raul Martin, PhD principal investigator
IOBA Eye Institute
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 Syndromes and Hyaluronic Acid, run by University of Valladolid at 1 site in Spain.
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 1 inclusion and 12 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 Jul 2024. 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 Spain. 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 Score (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2024.