Dry Eye SyndromesNCT05042960
Computer Screen Properties Study
A study testing Brightness in people with Dry Eye Syndromes, run by NYU Langone Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Brightness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 12 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult person (18+) with intact vision who uses computers
Who cannot join
- Children (<18 years)
- Adult person without intact vision
- Adult who does not use computer screens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dry Eye Syndromes
- Being tested
- Brightness
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrightnessOther
Changing the colors or brightness on the device (computer screen) for one month
| Study group | Role | What they receive |
|---|---|---|
| 50% brightness group | Experimental | Participants will be using a computer screen reducing screen brightness 50%. Receives: Other: Brightness |
| Light App group | Experimental | Participants in this group will use a modulating computer screen tone with flux or night shift app. Receives: Other: Brightness |
| Control group | No intervention | Participants in this group will be a control with no change in screen features |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of dry eye symptoms
Participants will complete a pre-intervention survey to measure the frequency of dry eye symptoms.
Measured: Day 1
The frequency of dry eye symptoms
Participants will complete a post-intervention survey to measure the frequency of dry eye symptoms.
Measured: Day 30
The severity of dry eye symptoms
Participants will complete a pre-intervention survey to measure the severity of dry eye symptoms.
Measured: Day 1
The severity of dry eye symptoms
Participants will complete a post-intervention survey to measure the severity of dry eye symptoms.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start15 Sep 2021
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leela Raju, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042960
- Sponsor's protocol ID
- 21-00472
- Status last verified
- Feb 2023
- First submitted
- 3 Sep 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Screen Brightness and Warm Tone Modulation on Dry Eye Symptoms
- ClinicalTrials.gov ID
- NCT05042960
- Acronym / sponsor ID
- 21-00472
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50% brightness group | Experimental | Other: BrightnessParticipants will be using a computer screen reducing screen brightness 50%. |
| Light App group | Experimental | Other: BrightnessParticipants in this group will use a modulating computer screen tone with flux or night shift app. |
| Control group | No intervention | –Participants in this group will be a control with no change in screen features |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult person (18+) with intact vision who uses computers
Key exclusion criteria (3 listed)
- Children (<18 years)
- Adult person without intact vision
- Adult who does not use computer screens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrightnessChanging the colors or brightness on the device (computer screen) for one month | Other | 50% brightness group, Light App group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leela Raju, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brightness in people with Dry Eye Syndromes, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of dry eye symptoms (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.