Dry Eye SyndromesPROTEGENCT06163989

Protecting the Eyes of Gamers With Lubricating Eyedrops

A study testing TheaLoz Duo Eyedrop in people with Dry Eye Syndromes and Computer Vision Syndrome, run by Aston University at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The excessive use of screens particularly amongst digital gamers can adversely impact the health of the surface of the eyes with symptoms and signs of surface damage. While strategies including limiting screen time exist, these may be ineffective given the widespread rise of digital device use and gaming culture in… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndromes, Computer Vision Syndrome
What is being tested?: TheaLoz Duo Eyedrop
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Sep 2024to 30 Dec 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals with dryness symptoms as assessed with the Ocular Surface Disease Index (OSDI score ≥ 13).
Individuals who play handheld console and computer-based games ≥ 2 hours everyday on average
Individuals who are comfortable and competent at using smartphone applications
Age ≥ 18 years, male or female
Able to provide written consent in English
Able to instil the treatment lubricating eyedrop on their own, and return any provided eyedrop bottle to the researcher used at the end of the treatment
Able to attend multiple visits (3 visits over 2 months)

Who cannot join

Pregnancy
Use of any topical ocular medical eyedrops or lubricants in the 1 week prior to starting the study or during the study period. Those who are using existing lubricating eyedrops and are interested in participating will be required to stop their lubricating eyedrops for 1 week prior to commencing the study
History of ocular surgery, trauma or infections in the past 6 months

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

James S Wolffsohn, PhD contact

+441212044400

dryeye@aston.ac.uk

United Kingdom1 site, 1 recruiting

School of Optometry, Aston University
Birmingham, West Midlands, B4 7ET
James Wolffsohn, +441212044400, dryeye@aston.ac.uk
Recruiting

Other trials in United Kingdom

About this study

Official title: The Protective Impact of TheaLoz Duo Eyedrop on the Ocular Surface in Hand-Held Console and Computer Game Users

The aim of this study is to investigate the protective effect of a lubricating eyedrop (TheaLoz Duo) on the surface of the eyes in handheld console and computer gamers. The main question it aims to answer is whether TheaLoz Duo could protect the surface of the eyes from dessication and alleviate symptoms of dry eye disease in handheld console and computer gamers.

Participants will receive either the lubricating eyedrop first for 1 month, followed by a control condition (no eyedrops) for another month, or the other way round. Participants will attend 3 visits in total, each separated by 1 month apart. During each visit, routine clinical assessments of the front of the eye will be conducted. Subsequent findings from this timely study will help improve care of the surface of the eyes for a growing population of gamers worldwide.

Read the detailed description

This study will be a randomized, outcome assessor-masked, cross-over clinical study to assess the potential impact of TheaLoz Duo lubricating eyedrop on symptoms and signs of dry eye disease in handheld console and computer gamers. All visits will be conducted at the Aston Dry Eye Clinic in Aston University, Birmingham, United Kingdom.

Conditions: Dry Eye Syndromes, Computer Vision Syndrome
Being tested: TheaLoz Duo Eyedrop
Keywords: Lubricating eyedrop, Artificial tears, Ocular surface
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.

TheaLoz Duo EyedropDrug
Also called Treatment Eyedrop
TheaLoz Duo lubricating eyedrop contains 3.0% trehalose and 0.15% sodium hyaluronate as active ingredients and will be used by participants everyday to instill 1 drop, 4 times a day in both eyes.

Study groups in NCT06163989
Study group	Role	What they receive
TheaLoz Duo in first month, crossover to control condition in second month	Experimental	The TheaLoz Duo eyedrop will be prescribed and used by the participant for 1 month. At the second visit 1 month later, the participant will return the TheaLoz Duo eyedrop bottle, and no eyedrops will be prescribed, and the participant monitored following 1 month. At the third and final visit 1 month later, the participant will return for a follow-up visit. Receives: Drug: TheaLoz Duo Eyedrop
Control condition in first month, crossover to TheaLoz Duo in second month	Active comparator	No eyedrops will be prescribed and the participant monitored for 1 month. At the second visit 1 month later, the participant will return and be prescribed TheaLoz Duo eyedrop and used by the participant for another 1 month. At the third and final visit 1 month later, the participant will return the TheaLoz Duo eyedrop bottle and complete the study visits. Receives: Drug: TheaLoz Duo Eyedrop

What is being measured

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

Change from Baseline in Ocular Surface Disease Index scores to the First Follow-Up 1 Month After Baseline
Validated questionnaire for assessing dry eye symptom severity and impact. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms and impact (Schiffman et al, 2000).
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Ocular Surface Disease Index scores to the Second Follow-Up 1 Month After the First Follow-Up
Validated questionnaire for assessing dry eye symptom severity and impact. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms and impact (Schiffman et al, 2000).
Measured: First follow-up to 1 month after the first follow-up

Secondary outcomes (23)

Change from Baseline in Computer Vision Syndrome Questionnaire scores to the First Follow-Up 1 Month After Baseline
Validated questionnaire for assessing the severity and frequency of eye strain when using a computer. The scores range from 0 to 32 (Seguí Mdel et al, 2015).
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Computer Vision Syndrome Questionnaire scores to the Second Follow-Up 1 Month After the First Follow-Up
Validated questionnaire for assessing the severity and frequency of eye strain when using a computer. The scores range from 0 to 32 (Seguí Mdel et al, 2015).
Measured: First follow-up to 1 month after the first follow-up
Change from Baseline in Visual Acuity to the First Follow-Up 1 Month After Baseline
Subjective measure of visual acuity using Logarithm of the Minimum Angle Resolution (logMAR) scoring, ranging from -0.30 which signify the ability to be able to resolve the smallest letters, to 1.00 which signify the ability to resolve only the largest letters.
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Visual Acuity to the Second Follow-Up 1 Month After the First Follow-Up
Subjective measure of visual acuity using Logarithm of the Minimum Angle Resolution (logMAR) scoring, ranging from -0.30 which signify the ability to be able to resolve the smallest letters, to 1.00 which signify the ability to resolve only the largest letters.
Measured: First follow-up to 1 month after the first follow-up
Change from Baseline in Tear Meniscus Height to the First Follow-Up 1 Month After Baseline
Measure of the volume of tears in mm using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Tear Meniscus Height to the Second Follow-Up 1 Month After the First Follow-Up
Measure of the volume of tears in mm using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.
Measured: First follow-up to 1 month after the first follow-up
Change from Baseline in Lipid Layer Pattern to the First Follow-Up 1 Month After Baseline
Subjective grading of the appearance of the lipid layer pattern as a surrogate measure of its thickness using the Oculus Keratograph 5M instrument. This ranges from Grade 1 indicating very thin lipid layer to Grade 6 indicating very thick lipid layer.
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Lipid Layer Pattern to the Second Follow-Up 1 Month After the First Follow-Up
Subjective grading of the appearance of the lipid layer pattern as a surrogate measure of its thickness using the Oculus Keratograph 5M instrument. This ranges from Grade 1 indicating very thin lipid layer to Grade 6 indicating very thick lipid layer.
Measured: First follow-up to 1 month after the first follow-up
Change from Baseline in Bulbar Conjunctival Hyperaemia to the First Follow-Up 1 Month After Baseline
Automated objective grading of the bulbar conjunctival redness using the Oculus Keratograph 5M instrument. This ranges from Grade 0 indicating no redness to Grade 4 indicating substantial redness.
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Bulbar Conjunctival Hyperaemia to the Second Follow-Up 1 Month After the First Follow-Up
Automated objective grading of the bulbar conjunctival redness using the Oculus Keratograph 5M instrument. This ranges from Grade 0 indicating no redness to Grade 4 indicating substantial redness.
Measured: First follow-up to 1 month after the first follow-up
Change from Baseline in Blink Rate to the First Follow-Up 1 Month After Baseline
Manual subjective count of the number of blinks using the Oculus Keratograph 5M instrument.
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Blink Rate to the Second Follow-Up 1 Month After the First Follow-Up
Manual subjective count of the number of blinks using the Oculus Keratograph 5M instrument.
Measured: First follow-up to 1 month after the first follow-up
Change from Baseline in Fluorescein Corneal Staining to the First Follow-Up 1 Month After Baseline
Subjective grading of the amount of corneal staining using fluorescein instillation, cobalt blue light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Fluorescein Corneal Staining to the Second Follow-Up 1 Month After the First Follow-Up
Subjective grading of the amount of corneal staining using fluorescein instillation, cobalt blue light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
Measured: First follow-up to 1 month after the first follow-up
Change from Baseline in Lissamine Green Bulbar Conjunctival Staining to the First Follow-Up 1 Month After Baseline
Subjective grading of the amount of bulbar conjunctival staining using lissamine green instillation, white light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Lissamine Green Bulbar Conjunctival Staining to the Second Follow-Up 1 Month After the First Follow-Up
Subjective grading of the amount of bulbar conjunctival staining using lissamine green instillation, white light illumination and the Oxford grading scale. This ranges from 0 with no staining to 5 with intense staining.
Measured: First follow-up to 1 month after the first follow-up
Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the First Follow-Up 1 Month After Baseline
Subjective grading of the amount of lid wiper epitheliopathy using lissamine green instillation and white light illumination. This grading ranges from 0 with no lid wiper epitheliopathy to 4 with severe lid wiper epitheliopathy
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Lissamine Green Lid Wiper Epitheliopathy to the Second Follow-Up 1 Month After the First Follow-Up
Subjective grading of the amount of lid wiper epitheliopathy using lissamine green instillation and white light illumination. This grading ranges from 0 with no lid wiper epitheliopathy to 4 with severe lid wiper epitheliopathy
Measured: First follow-up to 1 month after the first follow-up
Change from Baseline in Meibography Meiboscore to the First Follow-Up 1 Month After Baseline
Subjective grading of the amount of Meibomian gland loss using infrared imaging and the Pult meiboscore. This grading ranges from 0 with no gland loss to 4 with severe gland loss (Pult and Reide-Pult, 2013).
Measured: Baseline to 1 month after baseline
Change from First Follow-Up in Meibography Meiboscore to the Second Follow-Up 1 Month After the First Follow-Up
Subjective grading of the amount of Meibomian gland loss using infrared imaging and the Pult meiboscore. This grading ranges from 0 with no gland loss to 4 with severe gland loss (Pult and Reide-Pult, 2013).
Measured: First follow-up to 1 month after the first follow-up
Number of Participants with Dry Eye Disease at Baseline
The number of participants diagnosed with dry eye disease according to established clinical diagnostic criteria (Wolffsohn et al, 2017).
Measured: At baseline
Number of Participants with Dry Eye Disease at First Follow-Up
The number of participants diagnosed with dry eye disease according to established clinical diagnostic criteria (Wolffsohn et al, 2017).
Measured: At first follow-up 1 month after baseline
Number of Participants with Dry Eye Disease at SecondFollow-Up
The number of participants diagnosed with dry eye disease according to established clinical diagnostic criteria (Wolffsohn et al, 2017).
Measured: At second follow-up 1 month after first follow-up

Timeline

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

1 Sep 202430 Dec 2026

First posted11 Dec 2023
Study start1 Sep 2024
Primary completion30 Dec 2026 (estimated)
Study completion30 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Dry Eye SyndromesStudies 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: Crossover
Model description: Participants will be randomized to receive either the active treatment (TheaLoz Duo) or control condition (no eyedrops) at the first visit. The cross-over will occur one month following the first phase, followed by another month when the participant will be assessed again at the final visit.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06163989
Sponsor's protocol ID: HLS21135
Acronym: PROTEGE
Status last verified: Jan 2026
First submitted: 1 Dec 2023
Last updated: 21 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The investigators are planning to deposit deidentified datasets in a publicly and freely available data repository site.

Publications

Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.
PubMed 28736342
Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
PubMed 10815152
Pult H, Riede-Pult B. Comparison of subjective grading and objective assessment in meibography. Cont Lens Anterior Eye. 2013 Feb;36(1):22-7. doi: 10.1016/j.clae.2012.10.074. Epub 2012 Oct 27.
PubMed 23108007
Segui Mdel M, Cabrero-Garcia J, Crespo A, Verdu J, Ronda E. A reliable and valid questionnaire was developed to measure computer vision syndrome at the workplace. J Clin Epidemiol. 2015 Jun;68(6):662-73. doi: 10.1016/j.jclinepi.2015.01.015. Epub 2015 Jan 28.
PubMed 25744132

Interested in taking part?

James S Wolffsohn, PhD

+441212044400

dryeye@aston.ac.uk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Protective Impact of TheaLoz Duo Eyedrop on the Ocular Surface in Hand-Held Console and Computer Game Users
ClinicalTrials.gov ID: NCT06163989
Acronym / sponsor ID: PROTEGE / HLS21135
Conditions: Dry Eye Syndromes, Computer Vision Syndrome
Keywords: Lubricating eyedrop, Artificial tears, Ocular surface
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 28 participants (estimated)
Lead sponsor: Aston UniversityUniversity, hospital or other
Study start: 1 Sep 2024 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 30 Dec 2026 (estimated)
First posted: 11 Dec 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Participants will be randomized to receive either the active treatment (TheaLoz Duo) or control condition (no eyedrops) at the first visit. The cross-over will occur one month following the first phase, followed by another month when the participant will be assessed again at the final visit.

Arm	Type	Receives
TheaLoz Duo in first month, crossover to control condition in second month	Experimental	Drug: TheaLoz Duo EyedropThe TheaLoz Duo eyedrop will be prescribed and used by the participant for 1 month. At the second visit 1 month later, the participant will return the TheaLoz Duo eyedrop bottle, and no eyedrops will be prescribed, and the participant monitored following 1 month. At the third and final visit 1 month later, the participant will return for a follow-up visit.
Control condition in first month, crossover to TheaLoz Duo in second month	Active comparator	Drug: TheaLoz Duo EyedropNo eyedrops will be prescribed and the participant monitored for 1 month. At the second visit 1 month later, the participant will return and be prescribed TheaLoz Duo eyedrop and used by the participant for another 1 month. At the third and final visit 1 month later, the participant will return the TheaLoz Duo eyedrop bottle and complete the study visits.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Individuals with dryness symptoms as assessed with the Ocular Surface Disease Index (OSDI score ≥ 13).
Individuals who play handheld console and computer-based games ≥ 2 hours everyday on average
Individuals who are comfortable and competent at using smartphone applications
Age ≥ 18 years, male or female
Able to provide written consent in English

Key exclusion criteria (3 listed)

Pregnancy
Use of any topical ocular medical eyedrops or lubricants in the 1 week prior to starting the study or during the study period. Those who are using existing lubricating eyedrops and are interested in participating will be required to stop their lubricating eyedrops for 1 week prior to commencing the study
History of ocular surgery, trauma or infections in the past 6 months

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
TheaLoz Duo EyedropAlso: Treatment EyedropTheaLoz Duo lubricating eyedrop contains 3.0% trehalose and 0.15% sodium hyaluronate as active ingredients and will be used by participants everyday to instill 1 drop, 4 times a day in both eyes.	Drug	Control condition in first month, crossover to TheaLoz Duo in second month, TheaLoz Duo in first month, crossover to control condition in second month

Primary outcome

Change from Baseline in Ocular Surface Disease Index scores to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Validated questionnaire for assessing dry eye symptom severity and impact. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms and impact (Schiffman et al, 2000).
Change from First Follow-Up in Ocular Surface Disease Index scores to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Validated questionnaire for assessing dry eye symptom severity and impact. Scores range from 0 indicating no dry eye symptoms to 100 with severe dry eye symptoms and impact (Schiffman et al, 2000).

23 secondary outcomes

Change from Baseline in Computer Vision Syndrome Questionnaire scores to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Computer Vision Syndrome Questionnaire scores to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Change from Baseline in Visual Acuity to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Visual Acuity to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Change from Baseline in Tear Meniscus Height to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Tear Meniscus Height to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Change from Baseline in Lipid Layer Pattern to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Lipid Layer Pattern to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Change from Baseline in Bulbar Conjunctival Hyperaemia to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Bulbar Conjunctival Hyperaemia to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Change from Baseline in Blink Rate to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Blink Rate to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Change from Baseline in Fluorescein Corneal Staining to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Fluorescein Corneal Staining to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Change from Baseline in Lissamine Green Bulbar Conjunctival Staining to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Lissamine Green Bulbar Conjunctival Staining to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Lissamine Green Lid Wiper Epitheliopathy to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Change from Baseline in Meibography Meiboscore to the First Follow-Up 1 Month After Baseline
Time frame: Baseline to 1 month after baseline
Change from First Follow-Up in Meibography Meiboscore to the Second Follow-Up 1 Month After the First Follow-Up
Time frame: First follow-up to 1 month after the first follow-up
Number of Participants with Dry Eye Disease at Baseline
Time frame: At baseline
Number of Participants with Dry Eye Disease at First Follow-Up
Time frame: At first follow-up 1 month after baseline
Number of Participants with Dry Eye Disease at SecondFollow-Up
Time frame: At second follow-up 1 month after first follow-up

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Background: PubMed 28736342Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.
Background: PubMed 10815152Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
Background: PubMed 23108007Pult H, Riede-Pult B. Comparison of subjective grading and objective assessment in meibography. Cont Lens Anterior Eye. 2013 Feb;36(1):22-7. doi: 10.1016/j.clae.2012.10.074. Epub 2012 Oct 27.
Background: PubMed 25744132Segui Mdel M, Cabrero-Garcia J, Crespo A, Verdu J, Ronda E. A reliable and valid questionnaire was developed to measure computer vision syndrome at the workplace. J Clin Epidemiol. 2015 Jun;68(6):662-73. doi: 10.1016/j.jclinepi.2015.01.015. Epub 2015 Jan 28.
Individual participant dataSharing planned: Yes. The investigators are planning to deposit deidentified datasets in a publicly and freely available data repository site.

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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.

James S Wolffsohn, PhD contact

+441212044400

dryeye@aston.ac.uk

James S Wolffsohn, PhD study director

Aston 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 TheaLoz Duo Eyedrop in people with Dry Eye Syndromes and Computer Vision Syndrome, run by Aston University at 1 site in United Kingdom.

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 7 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: looking for participants now, as of the sponsor's last update on 21 Jan 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 United Kingdom. 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?

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 James S Wolffsohn, PhD (+441212044400, dryeye@aston.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Ocular Surface Disease Index scores to the First Follow-Up 1 Month After Baseline (time frame: Baseline to 1 month after baseline). The study lists 2 primary outcomes in all. 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 NCT06163989, which also lists 4 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 21 Jan 2026.