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Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use

Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06499753
Acronym
EMO-01
Enrollment
1033
Registered
2024-07-12
Start date
2020-02-01
Completion date
2022-01-31
Last updated
2024-07-17

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

Conditions

Dry Eye Syndromes, Hyaluronic Acid, OSDI

Brief 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 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.

Interventions

OTHERhigh molecular weight HA-based artificial tears

use of high molecular weight HA-based artificial tears three times per day

Sponsors

University of Valladolid
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

• Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher of each center

Exclusion criteria

* Hyperthyroidis * Rheumatism * Lupus * Autoimmune disease * Previous diagnosis of Dye Eye Disease * Cicatricial conjunctivitis * 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.

Design outcomes

Primary

MeasureTime frameDescription
OSDI Scorethree monthsChange in the Ocular Surface Disease Index (OSDI) score ranged from 0 (asymptomatic) to 100 (severe dry eye)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026