- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05042960
Computer Screen Properties Study
February 8, 2023 updated by: NYU Langone Health
Investigating the Effects of Screen Brightness and Warm Tone Modulation on Dry Eye Symptoms
The purpose of this study is to identify how various popular methods of changing computer screen settings affect dry eye symptoms (eye pain, grittiness, tearing, burning, etc.).
Specifically, this study will examine if there are differences in effects of blue light blocking (F.lux app or night shift) versus reducing screen brightness on the symptoms of dry eye.
Study Overview
Detailed Description
After the initial survey, participants will be randomized by a randomization tool internal to Redcap to be in one of three arms of intervention: no intervention, screen brightness reduction to 50%, and tone modulator application.
Instructions will be e-mailed to participants to explain the steps they must take depending on which treatment arm they are randomized to.
Adherence will be monitored and assessed at the time of post-intervention survey.
If participants have issues with the software of complying, they will be able to contact the research team at any point.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult person (18+) with intact vision who uses computers
Exclusion Criteria:
- Children (<18 years)
- Adult person without intact vision
- Adult who does not use computer screens
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 50% brightness group
Participants will be using a computer screen reducing screen brightness 50%.
|
Changing the colors or brightness on the device (computer screen) for one month
|
|
EXPERIMENTAL: Light App group
Participants in this group will use a modulating computer screen tone with flux or night shift app.
|
Changing the colors or brightness on the device (computer screen) for one month
|
|
NO_INTERVENTION: Control group
Participants in this group will be a control with no change in screen features
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The frequency of dry eye symptoms
Time Frame: Day 1
|
Participants will complete a pre-intervention survey to measure the frequency of dry eye symptoms.
|
Day 1
|
|
The frequency of dry eye symptoms
Time Frame: Day 30
|
Participants will complete a post-intervention survey to measure the frequency of dry eye symptoms.
|
Day 30
|
|
The severity of dry eye symptoms
Time Frame: Day 1
|
Participants will complete a pre-intervention survey to measure the severity of dry eye symptoms.
|
Day 1
|
|
The severity of dry eye symptoms
Time Frame: Day 30
|
Participants will complete a post-intervention survey to measure the severity of dry eye symptoms.
|
Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leela Raju, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 15, 2021
Primary Completion (ACTUAL)
January 12, 2023
Study Completion (ACTUAL)
January 12, 2023
Study Registration Dates
First Submitted
September 3, 2021
First Submitted That Met QC Criteria
September 3, 2021
First Posted (ACTUAL)
September 13, 2021
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2023
Last Update Submitted That Met QC Criteria
February 8, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-00472
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Immediately following publication.
No end date.
IPD Sharing Access Criteria
Requests should be directed to sachi.patil@nyulangone.org
To gain access, data requestors will need to sign a data access agreement.
Researchers who provide a methodologically sound proposal.Upon reasonable request
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.