NCT04637516

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

November 13, 2020

Last Update Submit

November 18, 2020

Conditions

Keywords

dry eye diseasecomputer workcomputer vision syndrome

Outcome Measures

Primary Outcomes (2)

  • Subjective improvement of dry eyes

    subjective improvement with OSDI questionnaire

    14 days

  • objective improvement of dry eyes

    objective improvement of tear film quality (NIBUT)

    14 days

Study Arms (2)

Programme Version 60 sec frequency

ACTIVE COMPARATOR

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

Device: Animation program "BlinkBlink"

Programme Version 300 sec frequency

PLACEBO COMPARATOR

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

Device: Animation program "BlinkBlink"

Interventions

Computer program that presents horizontal bars on the computer screen that move from above and below towards each other, mimicking a blink movement.

Programme Version 300 sec frequencyProgramme Version 60 sec frequency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • acute systemic disease
  • contact lens wear
  • asthenopia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Optometry, FHNW

Olten, Canton of Solothurn, 4600, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 26164310BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator does not know the order of versions tested by participants.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Subjects use two versions of the program for a set duration, separated by a washout phase. The order of versions applied is randomised.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 19, 2020

Study Start

April 1, 2018

Primary Completion

August 17, 2018

Study Completion

August 17, 2018

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations