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OpenTrials
Completed

NCT Number: NCT06505174

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IOBA Eye Institute

Valladolid, 47011, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hydroxypropyl Guar-based artificial tears four times per day

Other

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

Primary outcomes

  1. OSDI Score

    Time frame: One month

    Change in OSDI score

  2. CVSS17 Score

    Time frame: One month

    Change in CVSS17 score

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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