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

Completed

• Conditions: OSDI; Dry Eye Syndromes; Hyaluronic Acid

• Registration Number: NCT06499753
• Lead Sponsor: University of Valladolid

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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-11-30
• Study Completion: 2022-01-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-05
• Study First Posted: 2024-07-12
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1033

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OSDI Score	three months	Change in the Ocular Surface Disease Index (OSDI) score ranged from 0 (asymptomatic) to 100 (severe dry eye)

Trial Locations

Locations (1)

IOBA Eye Institute; 🇪🇸 Valladolid, Spain