Protecting the Eyes of Gamers With Lubricating Eyedrops

Dry Eye Syndromes Clinical Trial

— PROTEGE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06163989
• Other study ID #: HLS21135
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Aston University
• Contact: Jeremy Chung Bo Chiang, PhD
• Phone: +441212043934
• Email: j.chiang[@]aston.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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 control saline eyedrop solution 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: August 31, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Contact lens wear in the 2 weeks prior to starting the study or during study period

• Systemic conditions that can cause dry eye disease including diabetes and Sjögren's syndrome

• History of ocular surgery, trauma or infections

Related Conditions & MeSH terms

• Computer Vision Syndrome
• Dry Eye Syndromes
• Syndrome

Intervention

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.
• Saline Eyedrop
Saline 0.9% eyedrop is used as a control eyedrop and will be used by participants everyday to instill 1 drop, 4 times a day in both eyes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aston University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	Baseline to 1 month after baseline
Secondary	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).	First follow-up to 1 month after the first follow-up
Secondary	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.	Baseline to 1 month after baseline
Secondary	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.	First follow-up to 1 month after the first follow-up
Secondary	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.	Baseline to 1 month after baseline
Secondary	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.	First follow-up to 1 month after the first follow-up
Secondary	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.	Baseline to 1 month after baseline
Secondary	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.	First follow-up to 1 month after the first follow-up
Secondary	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.	Baseline to 1 month after baseline
Secondary	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.	First follow-up to 1 month after the first follow-up
Secondary	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.	Baseline to 1 month after baseline
Secondary	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.	First follow-up to 1 month after the first follow-up
Secondary	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.	Baseline to 1 month after baseline
Secondary	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.	First follow-up to 1 month after the first follow-up
Secondary	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.	Baseline to 1 month after baseline
Secondary	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.	First follow-up to 1 month after the first follow-up
Secondary	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	Baseline to 1 month after baseline
Secondary	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	First follow-up to 1 month after the first follow-up
Secondary	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).	Baseline to 1 month after baseline
Secondary	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).	First follow-up to 1 month after the first follow-up
Secondary	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).	At baseline
Secondary	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).	At first follow-up 1 month after baseline
Secondary	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).	At second follow-up 1 month after first follow-up