ClinicalTrials.gg
CompletedNCT07896395Updated Nov 2, 2026

20-20-20 Rule Plus Artificial Tears for Dry Eye

An interventional study of Artificial Tears (AT) and 20/20/20 rule in Dry Eye, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Sep 2025, registered Oct 2026).
Updated Nov 2, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Dry Eye Syndromes with a site in Egypt — 6 open to participants now, 7 under way, none of them phase 3. Dry Eye Syndromes · Egypt.

Enrollment
10th of 17
48 · median 50
Started
2025
with 5 others
No phase
12 of 24
3 open now
Registered
24th of 24
by date

Among the 24 studies in Dry Eye Syndromes with a site in Egypt, this one is the 10th largest by enrollment of the 17 interventional ones that give a count, is one of 6 that started in 2025, is one of 12 with no phase, and was the 24th registered.

Dry Eye Syndromes

1,367 studies on the registry are indexed under Dry Eye Syndromes; 208 are open to participants now.

Browse Dry Eye Syndromes studies →

Open to participants now

6 of the 24 studies in Dry Eye Syndromes with a site in Egypt are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.

This study: 20 Years to 50 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Dry Eye Syndromes with a site in Egypt, or all of them as a file.
02

Study summary

This study is for anyone struggling with dry, tired, or uncomfortable eyes, especially from long hours on screens.

Investigators all know that feeling after staring at a laptop or phone too long. This study from Zagazig University looks at a simple habit called the 20-20-20 rule: every 20 minutes, take a 20-second break to look at something about 20 feet away. Investigators want to see if doing this every day, along with participant's regular artificial tears, helps participants eyes feel better than tears alone.

If participant join, participant will use artificial tears as usual. Some participants will also be asked to practice the 20-20-20 rule throughout the day. Investigators will follow participant for about 8 weeks and check participant symptoms, tear film, and overall eye comfort with simple eye exams and questionnaires.

There is no experimental drug involved, just a daily habit Investigators hope will make standard treatment work better. The study was approved by the Institutional Review Board, Faculty of Medicine, Zagazig University on 07-September-2024.

Read the detailed description
  • Study Design:* Randomized controlled trial, 1 year total, 3 months per participant, at Ophthalmology Department, Zagazig University.
  • Population:* 48 IT employees at Zagazig University, age 20-50, digital screen use >=3 hours/day, mild-to-moderate dry eye. 24 per group.

*Intervention:*

  • Group A (Control, n=24): Preservative-free sodium hyaluronate artificial tears (single-dose units), 1 drop in each eye, 4 times daily for 3 months.
  • Group B (Experimental, n=24): Same artificial tears (same dose/duration) + 20-20-20 rule instructions throughout the workday, reinforced via eye-blink reminder application for 3 months.

    • Follow-up:* Baseline, Month 1, Month 2, Month 3. At each visit: OSDI questionnaire and Dry Eye Analyzer SLM-6E(A) assessment including NIBUT, TMH, lipid layer, bulbar redness scan, meibomian gland opening and meibomian gland dysfunction.
    • Primary Outcome:* Change in OSDI and NIBUT from baseline to Month 3.
    • Secondary Outcomes:* Change in TMH, lipid layer, red scan, meibomian gland parameters.
    • Sample Size:* 48 total (24 per group), calculated using OpenEpi with 95% CI and 80% power.
03

Conditions studied

  • Dry Eye

Browse trials for

Keywords

  • 20-20-20 Rule
  • Artificial Tears
  • Computer Vision Syndrome
  • Digital Eye Strain
  • dry eye analyzer
  • OSDI
04

Who can participate

The criteria were revised on the registry on Nov 2, 2026. See what changed

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria:

  • Age 25 to 50 years
  • Use of digital screens for at least 3 hours per day
  • Clinical diagnosis of mild-to-moderate dry eye disease based on Ocular Surface Disease Index (OSDI)
  • IT employee at Zagazig University (occupationally exposed to digital screens)
  • Willing to participate and provide written

Exclusion Criteria:

  • History of ocular surgery within the previous year, including refractive surgery
  • Contact lens wear
  • Use of ocular medications other than artificial tears
  • or systemic disease affecting the ocular surface
  • Known ocular surface disorders
  • Active ocular infection or inflammation
  • Single-eyed participants (only one functional eye)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Arm 1:* Artificial Tears

    \*Arm 1 Description:\* Preservative-free artificial tears (sodium hyaluronate), 1 drop in each affected eye 4 times daily for 3 months. No 20-20-20 rule intervention.

    Drug: Artificial Tears (AT)

  • Experimental
    Arm 2 (Artificial Tears + 20-20-20 Rule)

    \*Arm 2 Description:\* Same artificial tears regimen as Arm 1 (1 drop in each affected eye 4 times daily for 3 months) PLUS the 20-20-20 rule (every 20 minutes, look at something 20 feet away for 20 seconds), reinforced by an eye-blink reminder application during work hours for 3 months.

    Drug: Artificial Tears (AT) · Behavioral: 20/20/20 rule

Interventions

  • 1\. Artificial Tears (Drug): for arm 1 Preservative-free sodium hyaluronate ophthalmic solution, 1 drop in each eye 4 times daily for 3 months. Standard lubricating therapy for video display terminal-associated dry eye, given to both arms as background treatment.

  • Behavioral20/20/20 rule

    Participants are instructed to follow the 20-20-20 rule during all video display terminal use: every 20 minutes of continuous screen work, look at an object at least 20 feet (6 meters) away for at least 20 seconds, accompanied by 5 conscious, complete blinks. To reinforce adherence, participants install an eye-blink reminder application on their phone/work computer that prompts every 20 minutes during work hours. Training on the rule is provided at baseline with a written leaflet. Duration: throughout the 3-month study period, during work hours (approx. 8 hours/day).

06

What researchers measure

Primary outcomes

  1. Change in Ocular Surface Disease Index (OSDI) score from baseline to 3 months.

    OSDI is a 12-item validated questionnaire scored 0-100, with higher scores indicating more severe symptoms.

    Time frame: Assessed at baseline, 6 weeks, and 3 months

Secondary outcomes

  1. Change in Non-Invasive Keratograph Break-Up Time (NIKBUT)

    First and average NIKBUT in seconds, measured automatically by the Dry Eye Analyzer.

    Time frame: Assessed at baseline, 6 weeks, and 3 months.

  2. Change in Central Lower Tear Meniscus Height (TMH)

    Central lower tear meniscus height in mm, measured by the Dry Eye Analyzer.

    Time frame: Assessed at baseline, 6 weeks, and 3 months.

  3. Change in Bulbar Conjunctival Redness Score

    Objective bulbar redness graded 0-4 by the analyzer's automated R-scan.

    Time frame: Assessed at baseline, 6 weeks, and 3 months.

  4. Change in Meibomian Gland Loss

    Percentage of meibomian gland loss in upper and lower eyelids assessed by infrared meibography using the analyzer.

    Time frame: Assessed at baseline, 6 weeks and 3 months

07

Study locations

1 site
  • Ophthalmology Department, Zagazig University Hospital
    Zagazig, Sharkeya 445511, Egypt
08

References and documents

Publications

  • El-Mashed GY, Salama MAA, Srour LSS, Saleh AMA; Artificial Tears Alone versus Combined Artificial Tears and the 20-20-20 Rule in the Management of Dry Eye in Digital Device Users; Unpublished manuscript, Ophthalmology Department, Faculty of Medicine, Zagazig University; 2025; -;

Individual participant data

Plan to share: Yes — De-identified Individual Participant Data (IPD) for all 48 participants will be shared, including:Demographics: Age, Sex, Occupation (IT employee)Treatment Assignment: Group A (Preservative-free artificial tears 4x daily) vs Group B (Same artificial tears + 20-20-20 rule with reminder app)Visit Data at Baseline, First Follow-up (1 month), and Second Follow-up (3 months):Ocular Surface Disease Index (OSDI) scoreNon-invasive tear break-up time (NIBUT) (seconds)Tear Meniscus Height (TMH) (mm)Lipid layer assessmentBulbar redness scanMeibomian gland opening (Normal/Mild/Moderate)Meibomian gland dysfunction (MGD) score (0/1/2)Data will be provided as a de-identified participant-level dataset with a data dictionary, along with the Study Protocol and Statistical Analysis Plan.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Beginning 3 months and ending 5 years after publication

Access criteria: Who can access: De-identified IPD and supporting documents will be made available to qualified researchers, academic institutions, and healthcare professionals who submit a scientifically sound proposal.What can be accessed: De-identified individual participant-level dataset for the 48 participants (48 eyes), including demographics, treatment assignment, OSDI scores, Dry Eye Analyzer parameters (NIBUT, TMH, lipid layer, red scan, meibomian gland opening, MGD) at baseline and follow-ups, plus the Study Protocol, Statistical Analysis Plan, and Informed Consent Form with Data Dictionary. No identifiable personal information will be shared.How to access: Requests should be sent to the Corresponding Author, Lillian Samir Salama Srour, Ophthalmology Department, Faculty of Medicine, Zagazig University, Egypt, via the faculty contact http://en.medicine.zu.edu.eg/faculty/default. Requests must include a study proposal and analysis plan. Upon approval by the study team and Zagazig University IRB

Data sharing details ↗ · en.medicine.zu.edu.eg

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2025 to primary completion in Mar 2026, 6 months.

Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's 6 months is below that.

Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Oct 27, 2026
StartActual
Sep 10, 2025
Primary completionActual
Mar 31, 2026
CompletionActual
Mar 31, 2026
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
Criteria largely rewritten (18 changes)
What changed in the criteria
  • AddedInclusion Criteria:
  • AddedInclusion Criteria:
  • AddedAge 25 to 50 years
  • AddedUse of digital screens for at least 3 hours per day
  • AddedClinical diagnosis of mild-to-moderate dry eye disease based on Ocular Surface Disease Index (OSDI)
  • AddedIT employee at Zagazig University (occupationally exposed to digital screens)
  • AddedWilling to participate and provide written informed consent
  • AddedExclusion Criteria:
  • AddedHistory of ocular surgery within the previous year, including refractive surgery
  • AddedContact lens wear
  • AddedUse of ocular medications other than artificial tears
  • AddedAutoimmune or systemic disease affecting the ocular surface
  • AddedKnown ocular surface disorders
  • AddedActive ocular infection or inflammation
  • AddedSingle-eyed participants (only one functional eye)
Inclusion criteria
  • RemovedAge 18 to 45 years, both sexesVideo Display Terminal (VDT) use ≥ 4 hours/day for work/studyDiagnosis of Dry Eye Disease: OSDI score ≥ 13 AND Non-Invasive Keratograph Break-Up Time (NIKBUT) < 10 seconds on Dry Eye AnalyzerWilling and able to follow the 20-20-20 rule (for Arm 2) and instill artificial tears as instructedSigned informed consent
Exclusion criteria
  • RemovedActive ocular infection, inflammation, allergy, or traumaContact lens wear (current or within 2 weeks)Previous ocular surgery or laser procedureUse of anti-glaucoma medications or topical steroids/NSAIDsSystemic diseases known to cause dry eye (e.g., Sjögren's syndrome, rheumatoid arthritis, SLE)Systemic medications affecting tear secretion (e.g., antihistamines, antidepressants, isotretinoin) - unless stable dose for >3 monthsPregnancy or lactationParticipation in another clinical trial within 30 days
  • Removed-
Nov 2, 2026
Registered
First appeared on the registry
Oct 27, 2026
Show all 2 updates
  1. Nov 2, 2026
    Eligibility Criteria largely rewritten (18 changes)
    What changed in the criteria
    • AddedInclusion Criteria:
    • AddedInclusion Criteria:
    • AddedAge 25 to 50 years
    • AddedUse of digital screens for at least 3 hours per day
    • AddedClinical diagnosis of mild-to-moderate dry eye disease based on Ocular Surface Disease Index (OSDI)
    • AddedIT employee at Zagazig University (occupationally exposed to digital screens)
    • AddedWilling to participate and provide written informed consent
    • AddedExclusion Criteria:
    • AddedHistory of ocular surgery within the previous year, including refractive surgery
    • AddedContact lens wear
    • AddedUse of ocular medications other than artificial tears
    • AddedAutoimmune or systemic disease affecting the ocular surface
    • AddedKnown ocular surface disorders
    • AddedActive ocular infection or inflammation
    • AddedSingle-eyed participants (only one functional eye)
    Inclusion criteria
    • RemovedAge 18 to 45 years, both sexesVideo Display Terminal (VDT) use ≥ 4 hours/day for work/studyDiagnosis of Dry Eye Disease: OSDI score ≥ 13 AND Non-Invasive Keratograph Break-Up Time (NIKBUT) < 10 seconds on Dry Eye AnalyzerWilling and able to follow the 20-20-20 rule (for Arm 2) and instill artificial tears as instructedSigned informed consent
    Exclusion criteria
    • RemovedActive ocular infection, inflammation, allergy, or traumaContact lens wear (current or within 2 weeks)Previous ocular surgery or laser procedureUse of anti-glaucoma medications or topical steroids/NSAIDsSystemic diseases known to cause dry eye (e.g., Sjögren's syndrome, rheumatoid arthritis, SLE)Systemic medications affecting tear secretion (e.g., antihistamines, antidepressants, isotretinoin) - unless stable dose for >3 monthsPregnancy or lactationParticipation in another clinical trial within 30 days
    • Removed-
    + 3 other changes: responsible party, description and conditions
  2. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07896395
Lead sponsor
Zagazig University
Responsible party
alaa mohmamed ahmed saleh (Lecturer of ophthalmology, zagazig universiity, Zagazig University) — Principal investigator
First posted
Oct 27, 2026
Start date
Sep 10, 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026
Last update
Nov 2, 2026

Study contacts

Alaa M Saleh, MD
principal investigator · Zagazig University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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