NCT06499753

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,033

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

July 5, 2024

Last Update Submit

July 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • OSDI Score

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

    three months

Interventions

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health volunteers

You may qualify if:

  • Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher of each center

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IOBA Eye Institute

Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Raul Martin, PhD

    IOBA Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 12, 2024

Study Start

February 1, 2020

Primary Completion

November 30, 2020

Study Completion

January 31, 2022

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Data will be available by request to PI

Locations