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

NCT ID: NCT06499753

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1033 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-01-31

Brief Summary

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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

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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

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Dry Eye Syndromes Hyaluronic Acid OSDI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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high molecular weight HA-based artificial tears

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valladolid

OTHER

Sponsor Role lead

Responsible Party

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Raul Martin Herranz

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raul Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

IOBA Eye Institute

Locations

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IOBA Eye Institute

Valladolid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UVaGiO-PI201606

Identifier Type: -

Identifier Source: org_study_id

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