Skip to main content
OpenTrials
Completed

NCT Number: NCT06499753

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IOBA Eye Institute

Valladolid, 47011, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

high molecular weight HA-based artificial tears

Other

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

Primary outcomes

  1. OSDI Score

    Time frame: three months

    Change in the Ocular Surface Disease Index (OSDI) score ranged from 0 (asymptomatic) to 100 (severe dry eye)

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Registry information

Acronym: EMO-01

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Jul 12, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.