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

Sponsor

University of Applied Sciences and Arts Northwestern Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT04637516

Collaborator

(none)

Enrollment

Location

Arms

4.5

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes Computer Vision Syndrome	Device: Animation program "BlinkBlink"	N/A

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

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Investigator)

Masking Description:

The investigator does not know the order of versions tested by participants.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Aug 17, 2018

Actual Study Completion Date :

Aug 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Programme Version 60 sec frequency This version of the program "BlinkBlink" has a presentation frequency of 60 sec	Device: 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.
Placebo Comparator: Programme Version 300 sec frequency This version of the program "BlinkBlink" has a presentation frequency of 300 sec	Device: 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.

Arm

Intervention/Treatment

Active Comparator: Programme Version 60 sec frequency

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

Device: 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.

Placebo Comparator: Programme Version 300 sec frequency

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

Device: 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.

Outcome Measures

Primary Outcome Measures

Subjective improvement of dry eyes [14 days]
subjective improvement with OSDI questionnaire
objective improvement of dry eyes [14 days]
objective improvement of tear film quality (NIBUT)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.