Protecting the Eyes of Gamers With Lubricating Eyedrops
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAston University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
TheaLoz Duo Eyedrop
DrugTheaLoz 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.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: TheaLoz Duo in first month, crossover to control condition in second monthExperimental treatment 1 intervention
Group B: Control condition in first month, crossover to TheaLoz Duo in second monthActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline to 1 month after baseline2
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).
Time frame
First follow-up to 1 month after the first follow-upSecondary outcomes
1
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).
Time frame
Baseline to 1 month after baseline2
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).
Time frame
First follow-up to 1 month after the first follow-up3
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.
Time frame
Baseline to 1 month after baseline4
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.
Time frame
First follow-up to 1 month after the first follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov