Protecting the Eyes of Gamers With Lubricating Eyedrops

NCT06163989 | Recruiting

• 1 other identifier: HLS21135
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 the modern era. There is limited evidence for the protective effect of lubricating eyedrops on the ocular surface for handheld console and computer gamers. 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.

Conditions

Dry Eye Syndromes; Computer Vision Syndrome

Keywords

Lubricating eyedrop; Artificial tears; Ocular surface

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  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

  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

  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

  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

  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

  Baseline to 1 month after baseline

Study Arms (2)

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.

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.

Drug: TheaLoz Duo Eyedrop

Interventions

TheaLoz Duo Eyedrop DRUG

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.

Also known as: Treatment Eyedrop

Control condition in first month, crossover to TheaLoz Duo in second month; TheaLoz Duo in first month, crossover to control condition in second month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aston University: lead

Study Sites (1)

School of Optometry, Aston University

Birmingham, West Midlands, B4 7ET, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 28736342 BACKGROUND

• 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.

  PMID: 10815152 BACKGROUND

• 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.

  PMID: 23108007 BACKGROUND

• 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.

  PMID: 25744132 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• James S Wolffsohn, PhD

  Aston University

  STUDY DIRECTOR

Central Study Contacts

James S Wolffsohn, PhD

CONTACT

+441212044400; dryeye@aston.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Associate

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available at the end of the study before publication of the findings in a peer-reviewed journal.
• Access Criteria: The dataset will be publicly and freely available.

Locations

GB (1)