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CompletedNCT06499753EMO-01Updated Jul 17, 2024

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

An observational study in Dry Eye Syndromes, Hyaluronic Acid and OSDI, sponsored by University of Valladolid. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by University of Valladolid · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,033
Ages
18 Years to 90 Years
Sex
All
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Study 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

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.

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Conditions studied

  • Dry Eye Syndromes
  • Hyaluronic Acid
  • OSDI

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03

In context

Dry Eye Syndromes

1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.

This study's enrollment of 1,033 is above the median of 89 across 176 observational studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

University of Valladolid is the lead sponsor of 33 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Health volunteers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,033 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Interventions

  • Otherhigh molecular weight HA-based artificial tears

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

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What researchers measure

Primary outcomes

  1. OSDI Score

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

    Time frame: three months

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Study locations

1 site
  • IOBA Eye Institute
    Valladolid, 47011, Spain
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References and documents

Individual participant data

Plan to share: No — Data will be available by request to PI

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06499753
Lead sponsor
University of Valladolid
Responsible party
Raul Martin Herranz (PhD, University of Valladolid) — Principal investigator
First posted
Jul 12, 2024
Start date
Feb 1, 2020
Primary completion
Nov 30, 2020
Completion
Jan 31, 2022
Last update
Jul 17, 2024

Study contacts

Raul Martin, PhD
principal investigator · IOBA Eye Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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