Differences in Dry Eye Symptoms Related to Geographic Location in Spain and Impact of Artificial Tears Use (EMO-01)

July 16, 2024 updated by: Raul Martin Herranz, University of Valladolid
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1033

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47011
        • IOBA Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Health volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI Score
Time Frame: three months
Change in the Ocular Surface Disease Index (OSDI) score ranged from 0 (asymptomatic) to 100 (severe dry eye)
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valladolid

Investigators

  • Principal Investigator: Raul Martin, PhD, IOBA Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVaGiO-PI201606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available by request to PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Syndromes

Clinical Trials on high molecular weight HA-based artificial tears

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe