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

July 10, 2024 updated by: Raul Martin Herranz, University of Valladolid
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47011
        • IOBA Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Use of hydroxypropyl Guar-based artificial tears four times per day
Other: Hydroxypropyl Guar-based artificial tears four times per day
Use of hydroxypropyl Guar-based artificial tears four times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI Score
Time Frame: One month
Change in OSDI score
One month
CVSS17 Score
Time Frame: One month
Change in CVSS17 score
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valladolid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVaGiO-PI222911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available by reasonable request to PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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