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Dry Eye SyndromesNCT07430137

Blink Reminders and Meibomian Gland Loss in Digital Screen Users

A study testing Digital Blink Reminder Software (BlinkEasy) and Visual Hygiene Education (20-20-20 Rule). in people with Dry Eye Syndromes and Meibomian Gland Dysfunction (Disorder), run by Asociación para Evitar la Ceguera en México.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This randomized clinical trial aims to evaluate if a blink reminder program ('BlinkEasy') reduces the progression of Meibomian gland loss in intensive digital screen users over three months , using infrared meibography as the primary structural measure. Read more about this study

Who is it for?
Ages 18 to 40 years
What is being tested?
Digital Blink Reminder Software (BlinkEasy) and Visual Hygiene Education (20-20-20 Rule).
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
No sites listed yet
Study dates
19 Feb 2026to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants aged 18 to 40 years.
  • Intensive digital screen users, defined as an average screen time of ≥4 hours per day for at least 3 days per week.
  • Ocular Surface Disease Index (OSDI) score ≥13 (indicating mild to severe symptoms).
  • Non-invasive tear break-up time (NIBUT) ≤10 seconds measured by infrared meibography.
  • Presence of visible Meibomian glands on baseline meibography, allowing for quantitative analysis.
  • Technical ability to install and operate the BlinkEasy software on their primary digital device.

Who cannot join

  • Active ocular disease, including infections, corneal ulcers, or acute conjunctivitis.
  • History of ocular surgery (e.g., refractive surgery, cataract extraction) or significant ocular injury.
  • Use of topical ophthalmic medications affecting the ocular surface (e.g., steroids, glaucoma medications, or cyclosporine) within the last 3 months.
  • Active use of contact lenses that cannot be suspended for the duration of the 12-week study period.
  • Systemic conditions known to affect the ocular surface (e.g., Sjögren's syndrome, Rheumatoid Arthritis).
  • Diagnosis of Diabetes Mellitus (Type 1 or Type 2).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

José Francisco Heredia González, MD contact

52 + 5513095969

heredia.04102001@gmail.com

Jorge Augusto Landetta Platonoff, MD contact

52 + 5583725429

joraulandgm@gmail.com

About this study

Official title: Effect of a Blink Reminder Program on the Progression of Meibomian Gland Loss in Intensive Digital Screen Users: a Randomized Controlled Trial With Infrared Meibography

This randomized clinical trial aims to evaluate if a blink reminder program ('BlinkEasy') reduces the progression of Meibomian gland loss in intensive digital screen users over three months , using infrared meibography as the primary structural measure. Additionally, the study will analyze changes in dry eye symptoms using the 12-item Ocular Surface Disease Index (OSDI) questionnaire and non-invasive tear break-up time (NIBUT).

Read the detailed description

The Ocular Surface Disease (OSD) in digital display terminal (VDT) users is considered a "lifestyle epidemic" affecting productivity and quality of life. High visual demand imposed by screens leads to a significant reduction in blink frequency and an increase in incomplete blinks. This blinking ineffectiveness results in tear film instability, reflected in a non-invasive tear break-up time (NIBUT) of <10 seconds , and is strongly correlated with Meibomian Gland Dysfunction (MGD), which determines the severity of dry eye in these users.

While standard preventive measures like the "20-20-20 rule" are commonly recommended, evidence regarding their impact on objective morphological parameters of the ocular surface is limited or inconsistent. This study addresses the critical gap in long-term randomized clinical trials (RCTs) evaluating the sustainability of digital behavioral modifications on glandular morphology.

This is a randomized, parallel-group (1:1), open-label clinical trial. Participants will be intensive digital screen users (defined as ≥4 hours per day for at least 3 days a week) aged 18 to 40 years, recruited from the Hospital de la Ceguera (APEC).

Intervention Groups:

Experimental Group: Participants will install the "BlinkEasy" software on their digital devices. The program will display a visual alert approximately 8 times per minute designed to induce complete blinks; participants are instructed to blink twice with each alert. Adherence will be recorded via automated system logs.

Control Group: Participants will receive standard visual hygiene education, including the 20-20-20 rule and basic recommendations on blinking and visual rest.

The primary objective is to evaluate whether active blink reminders reduce the progression of Meibomian gland loss over a 12-week period using infrared meibography (Keratograph 5M) as the primary structural measure. The study hypothesizes that the intervention will reduce the progression of Meibomian gland loss by at least 10-15% of the total glandular area (or ≥0.5 points in meiboscore) compared to the control group. Secondary outcomes include changes in dry eye symptoms (measured by the 12-item OSDI questionnaire) and functional tear film parameters (NIBUT)

Being tested
Digital Blink Reminder Software (BlinkEasy), Visual Hygiene Education (20-20-20 Rule).
Keywords
Dry eye, Blinking, Meibography, Digital Displays, Meibomian Gland Atrophy, BlinkEasy
Medical subject headings
Dry Eye Syndromes, Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Blink Reminder Software (BlinkEasy)Behavioural

    Also called Active Blink Reminder Program, Automated Blink Training Software, Computer-based Blink Alert System

    Participants will install the 'BlinkEasy' software on their primary digital display terminal (VDT). The application provides automated visual notifications at a frequency of approximately 8 reminders per minute, specifically designed to prompt full, voluntary blinks. Participants are instructed to perform two consecutive complete blinks upon each visual cue. The software operates during the user's active screen time throughout the 12-week study period. System logs will be recorded to monitor daily adherence and software usage time to ensure consistency in the intervention delivery.

  • Visual Hygiene Education (20-20-20 Rule).Behavioural

    Also called 20-20-20 Rule, Visual Hygiene Education, Standard Ergonomic Advice

    Participants will receive a standardized educational session and written materials on visual hygiene and ergonomic practices for screen use. The primary intervention is the '20-20-20 rule,' which instructs the user to take a 20-second break every 20 minutes of screen use by looking at an object at least 20 feet (6 meters) away to facilitate ocular muscle relaxation and natural blinking. This group will not use any automated reminder software. Adherence will be self-reported by participants during follow-up visits over the 12-week study period.

Study groups in NCT07430137
Study groupRoleWhat they receive
Experimental Group (BlinkEasy)ExperimentalUsers assigned to this arm will use the 'BlinkEasy' software for 12 weeks.
Receives: Behavioral: Digital Blink Reminder Software (BlinkEasy)
Control Group (Standard Care)Active comparatorUsers in this arm will follow the 20-20-20 visual hygiene rule for 12 weeks.
Receives: Behavioral: Visual Hygiene Education (20-20-20 Rule).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Meibomian Gland Dropout Area and Meiboscore.

    Quantitative and qualitative assessment of Meibomian gland loss using infrared meibography (Oculus Keratograph 5M). Glandular dropout will be measured as:

    Percentage of area loss: Calculated as the ratio of the area of lost glands to the total tarsal area (0-100%).

    Meiboscore (Jenvis Scale): A 4-point grading scale where 0 indicates no loss; 1 is ≤25% loss; 2 is 26-50% loss; 3 is 51-75% loss; and 4 is >75% loss.

    Both eyes will be evaluated independently. Stabilization or reduction in these parameters in the experimental group compared to the control group will be considered a positive outcome.

    Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks.

Secondary outcomes (6)
  1. Change from Baseline in Ocular Surface Disease Index (OSDI) Score.

    Assessment of dry eye symptoms and their impact on vision-related quality of life using the validated 12-item OSDI questionnaire. The total score is calculated on a scale of 0 to 100, where:

    0-12: Normal / No symptoms.

    13-22: Mild dry eye.

    23-32: Moderate dry eye.

    33-100: Severe dry eye.

    Higher scores indicate greater symptom severity and functional limitation.

    Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks.

  2. Change from Baseline in Non-Invasive Tear Break-Up Time (NIBUT).

    Evaluation of tear film stability using the Oculus Keratograph 5M. The NIBUT measures the time (in seconds) between a complete blink and the first appearance of a dry spot or distortion in the reflected Placido disc image on the corneal surface. A longer NIBUT indicates better tear film stability. Measurements will be taken for each eye independently.

    Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks.

  3. Change from Baseline in Mean Blink Rate (BPM).

    The average number of blinks per minute (bpm) recorded by the software during active screen sessions. This objective measure will evaluate the improvement in blinking frequency compared to the control group.

    Measured: Weekly average throughout the 12-week study period.

  4. Change from Baseline in Average Blink Duration.

    The mean duration of individual blinks measured in milliseconds (ms). An increase in duration may correlate with more complete and effective blinks for ocular surface lubrication.

    Measured: Weekly average throughout the 12-week study period.

  5. Reduction in Time Spent with Critical Blinking Deficiency.

    Total time (minutes/seconds) per session where the participant's blink rate falls below the threshold of 7.5 blinks per minute. This variable measures the software's ability to prevent "staring" episodes.

    Measured: Weekly total throughout the 12-week study period.

  6. Adherence to the Digital Intervention.

    Total screen time (hours and minutes) with the software active and the total number of blink alerts triggered and acknowledged during the study.

    Measured: Total accumulated over 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study start19 Feb 2026 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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
Model description
A randomized, parallel-group, open-label clinical trial with a 1:1 allocation ratio. Participants will be assigned to either the experimental group, receiving active blink training via 'BlinkEasy' software, or the control group, receiving standard visual hygiene education based on the 20-20-20 rule. Randomization will be employed to ensure unbiased assignment into each study arm. The study involves a 12-week follow-up period, with clinical evaluations conducted at baseline, 4, 8, and 12 weeks to compare longitudinal changes between groups.
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07430137
Sponsor's protocol ID
HGJF_001
Status last verified
Feb 2026
First submitted
18 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Singh S, Donthineni PR, Srivastav S, Jacobi C, Basu S, Paulsen F. Lacrimal and meibomian gland evaluation in dry eye disease: A mini-review. Indian J Ophthalmol. 2023 Apr;71(4):1090-1098. doi: 10.4103/IJO.IJO_2622_22.

    PubMed 37026239
  • Daniel E, Maguire MG, Pistilli M, Bunya VY, Massaro-Giordano GM, Smith E, Kadakia PA, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Grading and baseline characteristics of meibomian glands in meibography images and their clinical associations in the Dry Eye Assessment and Management (DREAM) study. Ocul Surf. 2019 Jul;17(3):491-501. doi: 10.1016/j.jtos.2019.04.003. Epub 2019 Apr 22.

    PubMed 31022469
  • Lapa I, Ferreira S, Mateus C, Rocha N, Rodrigues MA. Real-Time Blink Detection as an Indicator of Computer Vision Syndrome in Real-Life Settings: An Exploratory Study. Int J Environ Res Public Health. 2023 Mar 4;20(5):4569. doi: 10.3390/ijerph20054569.

    PubMed 36901579
  • Ashwini DL, Ve RS, Nosch D, Wilmot N. Efficacy of blink software in improving the blink rate and dry eye symptoms in visual display terminal users - A single-blinded randomized control trial. Indian J Ophthalmol. 2021 Oct;69(10):2643-2648. doi: 10.4103/ijo.IJO_3405_20.

    PubMed 34571605
  • 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.

    PubMed 26164310
  • Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017 Jul;15(3):334-365. doi: 10.1016/j.jtos.2017.05.003. Epub 2017 Jul 20.

    PubMed 28736337

Questions about this trial

What is this clinical trial studying?

A study testing Digital Blink Reminder Software (BlinkEasy) and Visual Hygiene Education (20-20-20 Rule). in people with Dry Eye Syndromes and Meibomian Gland Dysfunction (Disorder), run by Asociación para Evitar la Ceguera en México.

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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact José Francisco Heredia González, MD (52 + 5513095969, heredia.04102001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Meibomian Gland Dropout Area and Meiboscore. (time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07430137, which also lists 6 linked publications.

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 27 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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