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Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work

Primary Purpose

Dry Eye Syndromes, Computer Vision Syndrome

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Animation program "BlinkBlink"
Sponsored by
University of Applied Sciences and Arts Northwestern Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring dry eye disease, computer work, computer vision syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Optometry, FHNW

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Programme Version 60 sec frequency

Programme Version 300 sec frequency

Arm Description

This version of the program "BlinkBlink" has a presentation frequency of 60 sec

This version of the program "BlinkBlink" has a presentation frequency of 300 sec

Outcomes

Primary Outcome Measures

Subjective improvement of dry eyes
subjective improvement with OSDI questionnaire
objective improvement of dry eyes
objective improvement of tear film quality (NIBUT)

Secondary Outcome Measures

Full Information

First Posted
November 13, 2020
Last Updated
November 18, 2020
Sponsor
University of Applied Sciences and Arts Northwestern Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04637516
Brief Title
Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work
Official Title
Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
August 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Applied Sciences and Arts Northwestern Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Computer Vision Syndrome
Keywords
dry eye disease, computer work, computer vision syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Investigator
Masking Description
The investigator does not know the order of versions tested by participants.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Programme Version 60 sec frequency
Arm Type
Active Comparator
Arm Description
This version of the program "BlinkBlink" has a presentation frequency of 60 sec
Arm Title
Programme Version 300 sec frequency
Arm Type
Placebo Comparator
Arm Description
This version of the program "BlinkBlink" has a presentation frequency of 300 sec
Intervention Type
Device
Intervention Name(s)
Animation program "BlinkBlink"
Intervention Description
Computer program that presents horizontal bars on the computer screen that move from above and below towards each other, mimicking a blink movement.
Primary Outcome Measure Information:
Title
Subjective improvement of dry eyes
Description
subjective improvement with OSDI questionnaire
Time Frame
14 days
Title
objective improvement of dry eyes
Description
objective improvement of tear film quality (NIBUT)
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Optometry, FHNW
City
Olten
State/Province
Solothurn
ZIP/Postal Code
4600
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26164310
Citation
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.
Results Reference
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Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work

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