Digital Eye StrainNCT06505174
Effect of Treatment With Systane Ultra in Symptomatology and Visual Task Efficiency in Digital Device Users
An observational study of Digital Eye Strain and Computer Vision Syndrome, run by University of Valladolid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Digital Eye Strain, Computer Vision Syndrome, OSDI
- What is being tested?
- Hydroxypropyl Guar-based artificial tears four times per day
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2023to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
Study population: Healthy Volunteers
Who may be able to join
- 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))
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Digital Eye Strain, Computer Vision Syndrome, OSDI
- Being tested
- Hydroxypropyl Guar-based artificial tears four times per day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxypropyl Guar-based artificial tears four times per dayOther
Use of hydroxypropyl Guar-based artificial tears four times per day
| Study group | Role | What they receive |
|---|---|---|
| Use of hydroxypropyl Guar-based artificial tears four times per day | Use of hydroxypropyl Guar-based artificial tears four times per day Receives: Other: Hydroxypropyl Guar-based artificial tears four times per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI Score
Change in OSDI score
Measured: One month
CVSS17 Score
Change in CVSS17 score
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start10 Jan 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Eye StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Martin Herranz, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505174
- Sponsor's protocol ID
- UVaGiO-PI222911
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available by reasonable request to PI
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment With Systane Ultra in Symptomatology and Visual Task Efficiency in Digital Device Users
- ClinicalTrials.gov ID
- NCT06505174
- Acronym / sponsor ID
- UVaGiO-PI222911
- Conditions
- Digital Eye Strain, Computer Vision Syndrome, OSDI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of hydroxypropyl Guar-based artificial tears four times per day | – | Other: Hydroxypropyl Guar-based artificial tears four times per dayUse of hydroxypropyl Guar-based artificial tears four times per day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy Volunteers
Key inclusion criteria (5 listed)
- 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))
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxypropyl Guar-based artificial tears four times per dayUse of hydroxypropyl Guar-based artificial tears four times per day | Other | Use of hydroxypropyl Guar-based artificial tears four times per day |
Primary outcome
OSDI Score
Time frame: One month
Change in OSDI score
CVSS17 Score
Time frame: One month
Change in CVSS17 score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No. Data will be available by reasonable request to PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digital Eye Strain and Computer Vision Syndrome, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI Score (time frame: One month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.