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

NCT ID: NCT06505174

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Digital Eye Strain Computer Vision Syndrome OSDI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Hydroxypropyl Guar-based artificial tears four times per day

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydroxypropyl Guar-based artificial tears four times per day

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Valladolid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Raul Martin Herranz

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IOBA Eye Institute

Valladolid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UVaGiO-PI222911

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.