Dry EyeNCT07896395
20-20-20 Rule Plus Artificial Tears for Dry Eye
A study testing Artificial Tears (AT) and 20/20/20 rule in people with Dry Eye, run by Zagazig University at 1 site in Egypt.
Trial summary
This study is for anyone struggling with dry, tired, or uncomfortable eyes, especially from long hours on screens. We all know that feeling after staring at a laptop or phone too long. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Artificial Tears (AT) and 20/20/20 rule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2025to 31 Mar 2026
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 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
Who cannot join
- Active 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
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ophthalmology Department, Zagazig University Hospital
Zagazig, Sharkeya, 445511
About this study
Official title: Artificial Tears Alone Versus Combined Artificial Tears and the 20-20-20 Rule in the Management of Dry Eye in Digital Device Users
This study is for anyone struggling with dry, tired, or uncomfortable eyes, especially from long hours on screens.
We 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. We want to see if doing this every day, along with your regular artificial tears, helps your eyes feel better than tears alone.
Read more
If you join, you will use artificial tears as usual. Some participants will also be asked to practice the 20-20-20 rule throughout the day. We will follow you for about 8 weeks and check your symptoms, tear film, and overall eye comfort with simple eye exams and questionnaires.
There is no experimental drug involved, just a daily habit we 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.
- Conditions
- Dry Eye
- Being tested
- Artificial Tears (AT), 20/20/20 rule
- Keywords
- 20-20-20 Rule, Artificial Tears, Computer Vision Syndrome, Digital Eye Strain, OSDI, Tear Film, NIBUT
- 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.
Artificial Tears (AT)Drug
- 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.
20/20/20 ruleBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1:* Artificial Tears | Active comparator | *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. Receives: Drug: Artificial Tears (AT) |
| Arm 2 (Artificial Tears + 20-20-20 Rule) | Experimental | *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. Receives: Drug: Artificial Tears (AT); Behavioral: 20/20/20 rule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at baseline, 6 weeks, and 3 months
Secondary outcomes (4)
Change in Non-Invasive Keratograph Break-Up Time (NIKBUT)
First and average NIKBUT in seconds, measured automatically by the Dry Eye Analyzer.
Measured: Assessed at baseline, 6 weeks, and 3 months.
Change in Central Lower Tear Meniscus Height (TMH)
Central lower tear meniscus height in mm, measured by the Dry Eye Analyzer.
Measured: Assessed at baseline, 6 weeks, and 3 months.
Change in Bulbar Conjunctival Redness Score
Objective bulbar redness graded 0-4 by the analyzer's automated R-scan.
Measured: Assessed at baseline, 6 weeks, and 3 months.
Change in Meibomian Gland Loss
Percentage of meibomian gland loss in upper and lower eyelids assessed by infrared meibography using the analyzer.
Measured: Assessed at baseline, 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start10 Sep 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, randomized, parallel assignment, open-label study with 2 arms (1:1 allocation). 48 participants are randomized to 24 in Group A (control: preservative-free sodium hyaluronate artificial tears 1 drop in each eye 4 times daily for 3 months) and 24 in Group B (experimental: same artificial tears regimen plus 20-20-20 rule reinforced by eye-blink reminder application during workday for 3 months).
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, alaa mohmamed ahmed saleh, Zagazig University
- Investigators
- Alaa M Saleh, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896395
- Sponsor's protocol ID
- 1614
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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; -;
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Tears Alone Versus Combined Artificial Tears and the 20-20-20 Rule in the Management of Dry Eye in Digital Device Users
- ClinicalTrials.gov ID
- NCT07896395
- Acronym / sponsor ID
- 1614
- Conditions
- Dry Eye
- Keywords
- 20-20-20 Rule, Artificial Tears, Computer Vision Syndrome, Digital Eye Strain, OSDI, Tear Film, NIBUT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 27 Oct 2026 (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.
This study is for anyone struggling with dry, tired, or uncomfortable eyes, especially from long hours on screens.
We 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. We want to see if doing this every day, along with your regular artificial tears, helps your eyes feel better than tears alone.
If you join, you will use artificial tears as usual. Some participants will also be asked to practice the 20-20-20 rule throughout the day. We will follow you for about 8 weeks and check your symptoms, tear film, and overall eye comfort with simple eye exams and questionnaires.
There is no experimental drug involved, just a daily habit we 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, randomized, parallel assignment, open-label study with 2 arms (1:1 allocation). 48 participants are randomized to 24 in Group A (control: preservative-free sodium hyaluronate artificial tears 1 drop in each eye 4 times daily for 3 months) and 24 in Group B (experimental: same artificial tears regimen plus 20-20-20 rule reinforced by eye-blink reminder application during workday for 3 months).
| Arm | Type | Receives |
|---|---|---|
| Arm 1:* Artificial Tears | Active comparator | Drug: Artificial Tears (AT)*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. |
| Arm 2 (Artificial Tears + 20-20-20 Rule) | Experimental | Drug: Artificial Tears (AT), Behavioral: 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 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
Key exclusion criteria (2 listed)
- Active 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
- -
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 |
|---|---|---|
| Artificial Tears (AT)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. | Drug | Arm 1:* Artificial Tears, Arm 2 (Artificial Tears + 20-20-20 Rule) |
| 20/20/20 ruleParticipants 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). | Behavioural | Arm 2 (Artificial Tears + 20-20-20 Rule) |
Primary outcome
Change in Ocular Surface Disease Index (OSDI) score from baseline to 3 months.
Time frame: Assessed at baseline, 6 weeks, and 3 months
OSDI is a 12-item validated questionnaire scored 0-100, with higher scores indicating more severe symptoms.
4 secondary outcomes
Change in Non-Invasive Keratograph Break-Up Time (NIKBUT)
Time frame: Assessed at baseline, 6 weeks, and 3 months.
Change in Central Lower Tear Meniscus Height (TMH)
Time frame: Assessed at baseline, 6 weeks, and 3 months.
Change in Bulbar Conjunctival Redness Score
Time frame: Assessed at baseline, 6 weeks, and 3 months.
Change in Meibomian Gland Loss
Time frame: Assessed at baseline, 6 weeks and 3 months
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 27 Oct 2026.
- Results publicationEl-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; -;
- Email corresponding author, Zagazig University, via http://en.medicine.zu.edu.eg/faculty/default with proposal. De-identified IPD, protocol, SAP available 3mo-5yr after publication under agreement.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
Alaa M Saleh, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Tears (AT) and 20/20/20 rule in people with Dry Eye, run by Zagazig University at 1 site in Egypt.
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 2 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 27 Oct 2026. 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 Egypt. 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?
Change in Ocular Surface Disease Index (OSDI) score from baseline to 3 months. (time frame: Assessed at baseline, 6 weeks, and 3 months). 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 NCT07896395, which also lists 1 linked publication.
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 Oct 2026.