Dry Eye SyndromesNCT04637516
Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work
A study testing Animation program "BlinkBlink" in people with Dry Eye Syndromes and Computer Vision Syndrome, run by University of Applied Sciences and Arts Northwestern Switzerland at 1 site in Switzerland.
Trial summary
The program "BlinkBlink" was developed to alleviate dry eye symptoms during prolonged computer work. This study aimed to show subjective and objective improvement of dry eye problems in a sample size of office workers Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Computer Vision Syndrome
- What is being tested?
- Animation program "BlinkBlink"
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2018to 17 Aug 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- duration of computer work of at least six hours per day during at least four days per week
- OSDI score ≥ 18
- no active pathology on the anterior eye
- Snellen visual acuity of ≥ 0.8.
Who cannot join
- acute systemic disease
- contact lens wear
- asthenopia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute of Optometry, FHNW
Olten, Canton of Solothurn, 4600
About this study
The program "BlinkBlink" was developed to alleviate dry eye symptoms during prolonged computer work. This study aimed to show subjective and objective improvement of dry eye problems in a sample size of office workers
Read the detailed description
The increased use of digital devices and the resulting increase in near work has increased the prevalence of dry eye disease (DED).
Studies show that blink frequency reduced considerably during computer work, hence the tear film is spread less regularly over the anterior surface of the eye giving rise to an unstable tear film. This may lead to tired, dry eyes.
The aim of this study was to observe if the tear film quality and dry eye symptoms may improve with the use of the computer animation program "BlinkBlink" during prolonged computer work. Participating subjects test two versions of the program, whereby one version applies the animation in a much lower frequency, hence serving as a near placebo version. The testing order of the versions is randomized.
The variables tested in this study are non-invasive tear film break up (NIBUT) and subjective dry eye symptoms with the Ocular Surface Disease Index (OSDI) questionnaire.
- Conditions
- Dry Eye Syndromes, Computer Vision Syndrome
- Being tested
- Animation program "BlinkBlink"
- Keywords
- dry eye disease, computer work, computer vision syndrome
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation program "BlinkBlink"Device
Computer program that presents horizontal bars on the computer screen that move from above and below towards each other, mimicking a blink movement.
| Study group | Role | What they receive |
|---|---|---|
| Programme Version 60 sec frequency | Active comparator | This version of the program "BlinkBlink" has a presentation frequency of 60 sec Receives: Device: Animation program "BlinkBlink" |
| Programme Version 300 sec frequency | Placebo comparator | This version of the program "BlinkBlink" has a presentation frequency of 300 sec Receives: Device: Animation program "BlinkBlink" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective improvement of dry eyes
subjective improvement with OSDI questionnaire
Measured: 14 days
objective improvement of dry eyes
objective improvement of tear film quality (NIBUT)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Apr 2018
- Primary completion17 Aug 2018
- Study completion17 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects use two versions of the program for a set duration, separated by a washout phase. The order of versions applied is randomised.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences and Arts Northwestern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Nosch, University of Applied Sciences and Arts Northwestern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637516
- Sponsor's protocol ID
- 2018-00378
- Other IDs
- 2018
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nosch DS, Foppa C, Toth M, Joos RE. Blink Animation Software to Improve Blinking and Dry Eye Symptoms. Optom Vis Sci. 2015 Sep;92(9):e310-5. doi: 10.1097/OPX.0000000000000654.
PubMed 26164310
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work
- ClinicalTrials.gov ID
- NCT04637516
- Acronym / sponsor ID
- 2018-00378
- Conditions
- Dry Eye Syndromes, Computer Vision Syndrome
- Keywords
- dry eye disease, computer work, computer vision syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Applied Sciences and Arts Northwestern SwitzerlandUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 19 Nov 2020 (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.
The program "BlinkBlink" was developed to alleviate dry eye symptoms during prolonged computer work. This study aimed to show subjective and objective improvement of dry eye problems in a sample size of office workers
Detailed description
The increased use of digital devices and the resulting increase in near work has increased the prevalence of dry eye disease (DED).
Studies show that blink frequency reduced considerably during computer work, hence the tear film is spread less regularly over the anterior surface of the eye giving rise to an unstable tear film. This may lead to tired, dry eyes.
The aim of this study was to observe if the tear film quality and dry eye symptoms may improve with the use of the computer animation program "BlinkBlink" during prolonged computer work. Participating subjects test two versions of the program, whereby one version applies the animation in a much lower frequency, hence serving as a near placebo version. The testing order of the versions is randomized.
The variables tested in this study are non-invasive tear film break up (NIBUT) and subjective dry eye symptoms with the Ocular Surface Disease Index (OSDI) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Subjects use two versions of the program for a set duration, separated by a washout phase. The order of versions applied is randomised.
| Arm | Type | Receives |
|---|---|---|
| Programme Version 60 sec frequency | Active comparator | Device: Animation program "BlinkBlink"This version of the program "BlinkBlink" has a presentation frequency of 60 sec |
| Programme Version 300 sec frequency | Placebo comparator | Device: Animation program "BlinkBlink"This version of the program "BlinkBlink" has a presentation frequency of 300 sec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- duration of computer work of at least six hours per day during at least four days per week
- OSDI score ≥ 18
- no active pathology on the anterior eye
- Snellen visual acuity of ≥ 0.8.
Key exclusion criteria (3 listed)
- acute systemic disease
- contact lens wear
- asthenopia
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 |
|---|---|---|
| Animation program "BlinkBlink"Computer program that presents horizontal bars on the computer screen that move from above and below towards each other, mimicking a blink movement. | Device | Programme Version 300 sec frequency, Programme Version 60 sec frequency |
Primary outcome
Subjective improvement of dry eyes
Time frame: 14 days
subjective improvement with OSDI questionnaire
objective improvement of dry eyes
Time frame: 14 days
objective improvement of tear film quality (NIBUT)
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 19 Nov 2020.
- Background: PubMed 26164310Nosch DS, Foppa C, Toth M, Joos RE. Blink Animation Software to Improve Blinking and Dry Eye Symptoms. Optom Vis Sci. 2015 Sep;92(9):e310-5. doi: 10.1097/OPX.0000000000000654.
- Individual participant dataSharing planned: No
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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?
A study testing Animation program "BlinkBlink" in people with Dry Eye Syndromes and Computer Vision Syndrome, run by University of Applied Sciences and Arts Northwestern Switzerland at 1 site in Switzerland.
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 4 inclusion and 3 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 19 Nov 2020. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Subjective improvement of dry eyes (time frame: 14 days). 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?
On the ClinicalTrials.gov record for NCT04637516, which also lists 1 linked publication.
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 19 Nov 2020.