Clinical trial NCT06163989: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye Syndromes
Computer Vision Syndrome
Keywords: Lubricating eyedrop
Artificial tears
Ocular surface
Lead sponsor: Aston University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change from Baseline in Ocular Surface Disease Index scores to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Ocular Surface Disease Index scores to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
Secondary outcomes:
measure: Change from Baseline in Computer Vision Syndrome Questionnaire scores to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Computer Vision Syndrome Questionnaire scores to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Change from Baseline in Visual Acuity to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Visual Acuity to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Change from Baseline in Tear Meniscus Height to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Tear Meniscus Height to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Change from Baseline in Lipid Layer Pattern to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Lipid Layer Pattern to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Change from Baseline in Bulbar Conjunctival Hyperaemia to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Bulbar Conjunctival Hyperaemia to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Change from Baseline in Blink Rate to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Blink Rate to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Change from Baseline in Fluorescein Corneal Staining to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Fluorescein Corneal Staining to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Change from Baseline in Lissamine Green Bulbar Conjunctival Staining to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Lissamine Green Bulbar Conjunctival Staining to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Lissamine Green Lid Wiper Epitheliopathy to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Change from Baseline in Meibography Meiboscore to the First Follow-Up 1 Month After Baseline
timeFrame: Baseline to 1 month after baseline
measure: Change from First Follow-Up in Meibography Meiboscore to the Second Follow-Up 1 Month After the First Follow-Up
timeFrame: First follow-up to 1 month after the first follow-up
measure: Number of Participants with Dry Eye Disease at Baseline
timeFrame: At baseline
measure: Number of Participants with Dry Eye Disease at First Follow-Up
timeFrame: At first follow-up 1 month after baseline
measure: Number of Participants with Dry Eye Disease at SecondFollow-Up
timeFrame: At second follow-up 1 month after first follow-up
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: School of Optometry, Aston University
state: West Midlands
Study officials:
affiliation: Aston University
name: James S Wolffsohn, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.