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

Completed

• Conditions: Digital Eye Strain; Computer Vision Syndrome; OSDI
• Interventions: Other: Hydroxypropyl Guar-based artificial tears four times per day

• Registration Number: NCT06505174
• Lead Sponsor: University of Valladolid

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.

Detailed Description

Visual display terminal users (\>4h/day) with DES (CVSS17 score: ranged 29 to 42) and dryness (OSDI score: ranged 13 to 24) symptomatology were prescribed with preservative-free artificial tears (Systane Ultra UD, Alcon) four times a day for one month collecting OSDI and CVSS17 questionnaires in four visits \[screening (Day -7), initial (Day 0), one week (Day 7) and one month (Day 30)\].

Blink rate and number of eye fixations (collected with eye-tracker) in six simple computer tasks and out-loud reading speed were determined before and after performing all tasks on the computer. Tear film stability and ocular parameters were also measured.

Study Timeline

• Study Start: 2023-01-10
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• 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))

Exclusion Criteria

• 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
• Use of artificial tears or lubricants at least 7 days before inclusion in the study (recruitment visit).
• Any other ocular pathology or binocular conditions which may cause discomfort (e.g. heterophoric, accommodative, and eye movement disorders)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Use of hydroxypropyl Guar-based artificial tears four times per day	Hydroxypropyl Guar-based artificial tears four times per day	Use of hydroxypropyl Guar-based artificial tears four times per day

Primary Outcome Measures

Name	Time	Method
OSDI Score	One month	Change in OSDI score
CVSS17 Score	One month	Change in CVSS17 score

Trial Locations

Locations (1)

IOBA Eye Institute; 🇪🇸 Valladolid, Spain