Effect of Treatment With Systane Ultra in Symptomatology and Visual Task Efficiency in Digital Device Users

NCT06505174 | Completed

• 1 other identifier: UVaGiO-PI222911
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study assessed the effect of one month of use of preservative-free artificial tears (Systane Ultra UD, Alcon) on symptomatology related to digital eye strain (DES), visual task performance, and tear film stability in visual display terminal users.

Conditions

Digital Eye Strain; Computer Vision Syndrome; OSDI

Outcome Measures

Primary Outcomes (2)

• OSDI Score

  Change in OSDI score

  One month

• CVSS17 Score

  Change in CVSS17 score

  One month

Study Arms (1)

Use of hydroxypropyl Guar-based artificial tears four times per day

Use of hydroxypropyl Guar-based artificial tears four times per day

Other: Hydroxypropyl Guar-based artificial tears four times per day

Interventions

Hydroxypropyl Guar-based artificial tears four times per day OTHER

Use of hydroxypropyl Guar-based artificial tears four times per day

Use of hydroxypropyl Guar-based artificial tears four times per day

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy 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, receiving the information sheet and signing the informed consent.
• Eye discomfort related to dryness (OSDI score ranged from 13 to 24)
• Symptomatic digital device users (CVSS17 score ranged from 29 to 42 points - stages 3 and 4)
• Use of computer continuously for at least 4 hours per day (work week)
• Good best-corrected visual acuity (Visual acuity LogMar ≤ 0.00 for distance, intermediate (60cm) and near (40cm))

You may not qualify if:

• Systemic administration of drugs with a possible effect on the ocular surface.
• Topical administration of any drugs that can alter the ocular surface.
• Use of contact lenses
• Any other ocular pathology or binocular conditions which may cause discomfort (e.g. heterophoric, accommodative, and eye movement disorders)

Sponsors & Collaborators

• University of Valladolid: lead

Study Sites (1)

IOBA Eye Institute

Valladolid, 47011, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: January 10, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)