Blink Reminders and Meibomian Gland Loss in Digital Screen Users

NCT07430137 | Not Yet Recruiting

• 1 other identifier: HGJF_001
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction (Disorder)

Keywords

Dry eye; Blinking; Meibography; Digital Displays; Meibomian Gland Atrophy; BlinkEasy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• Change from Baseline in Ocular Surface Disease Index (OSDI) Score.

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

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

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

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

  Weekly average throughout the 12-week study period.

• Change from Baseline in Average Blink Duration.

  Weekly average throughout the 12-week study period.

• Reduction in Time Spent with Critical Blinking Deficiency.

  Weekly total throughout the 12-week study period.

Study Arms (2)

Experimental Group (BlinkEasy)

EXPERIMENTAL

Users assigned to this arm will use the 'BlinkEasy' software for 12 weeks.

Behavioral: Digital Blink Reminder Software (BlinkEasy)

Control Group (Standard Care)

ACTIVE COMPARATOR

Users in this arm will follow the 20-20-20 visual hygiene rule for 12 weeks.

Behavioral: Visual Hygiene Education (20-20-20 Rule).

Interventions

Digital Blink Reminder Software (BlinkEasy) BEHAVIORAL

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.

Also known as: Active Blink Reminder Program, Automated Blink Training Software, Computer-based Blink Alert System

Experimental Group (BlinkEasy)

Visual Hygiene Education (20-20-20 Rule). BEHAVIORAL

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.

Also known as: 20-20-20 Rule, Visual Hygiene Education, Standard Ergonomic Advice

Control Group (Standard Care)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Related Publications (6)

• 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.

  PMID: 37026239 BACKGROUND

• 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.

  PMID: 31022469 BACKGROUND

• 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.

  PMID: 36901579 BACKGROUND

• 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.

  PMID: 34571605 BACKGROUND

• 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: 26164310 BACKGROUND

• 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.

  PMID: 28736337 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Ana Mercedes Garcia Albisua, MD

  Asociación para Evitar la Ceguera en México (APEC).

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Francisco Heredia González, MD

CONTACT

52 + 5513095969; heredia.04102001@gmail.com

Jorge Augusto Landetta Platonoff, MD

CONTACT

52 + 5583725429; joraulandgm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The trial is open-label because the nature of the behavioral intervention (installation of the 'BlinkEasy' software) does not allow for the masking of participants or the personnel delivering the training. To maintain the integrity of the objective results, all clinical measurements-including meibography for Meiboscore and NIBUT-will be performed following strictly standardized protocols.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share