Protecting the Eyes of Gamers With Lubricating Eyedrops

Official title

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

Overview

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.

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.

Interventions

• Drug TheaLoz Duo 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.

Primary outcome measures

• 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]
• 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]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• School of Optometry, Aston University — Birmingham

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. PMID 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. PMID 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. PMID 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. PMID 25744132

Identifiers

NCT: NCT06163989 · HLS21135

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗