- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04637516
Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Solothurn
-
Olten, Solothurn, Switzerland, 4600
- Institute of Optometry, FHNW
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- acute systemic disease
- contact lens wear
- asthenopia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Programme Version 60 sec frequency
This version of the program "BlinkBlink" has a presentation frequency of 60 sec
|
Computer program that presents horizontal bars on the computer screen that move from above and below towards each other, mimicking a blink movement.
|
Placebo Comparator: Programme Version 300 sec frequency
This version of the program "BlinkBlink" has a presentation frequency of 300 sec
|
Computer program that presents horizontal bars on the computer screen that move from above and below towards each other, mimicking a blink movement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective improvement of dry eyes
Time Frame: 14 days
|
subjective improvement with OSDI questionnaire
|
14 days
|
objective improvement of dry eyes
Time Frame: 14 days
|
objective improvement of tear film quality (NIBUT)
|
14 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-00378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Dry Eye Syndromes
-
Singapore National Eye CentreCompleted
-
Singapore National Eye CentreCompleted
-
Alcon ResearchCompletedVisual Performance | Dry Eye Symptoms
-
Alcon ResearchCompletedModerate to Severe Dry Eye
-
Centre for Contact Lens ResearchCoopervision, Inc.CompletedContact Lens Related Dry EyeCanada
-
OptovueCompleted
-
Kao (Taiwan) CorporationChang Gung Memorial HospitalCompletedEye Fatigue | Dry Eye SymptomTaiwan
-
Bausch & Lomb IncorporatedCompletedDry Eye Disease (DED)United States
-
He Eye HospitalCompleted
-
Johnson & Johnson Vision Care, Inc.Completed
Clinical Trials on Animation program "BlinkBlink"
-
Hospital Universitario Fundación AlcorcónInstituto de Salud Carlos III; European UnionRecruitingRotator Cuff Tendinitis | Rotator Cuff Impingement Syndrome | Rotator Cuff Related Shoulder PainSpain
-
Atatürk UniversityCompletedSurgery | Educational ProblemsTurkey
-
Kutahya Health Sciences UniversityActive, not recruitingTime Perception AlteredTurkey
-
Siirt UniversityCompleted
-
NHS LothianCompletedAbortion in First Trimester | Abortion EarlySweden, United Kingdom, France
-
Kutahya Health Sciences UniversityHacettepe UniversityActive, not recruitingAttention Deficit Disorder With HyperactivityTurkey
-
Sakarya UniversityCompleted
-
Kastamonu UniversityCompleted
-
University of HaifaRambam Health Care CampusCompleted
-
Pamukkale UniversityCompletedType 1 Diabetes MellitusTurkey