Protecting the Eyes of Gamers With Lubricating Eyedrops (PROTEGE)

Aston University

Status: Enrolling

Conditions: Computer Vision Syndrome; Dry Eye Syndromes

Treatments: Drug: TheaLoz Duo Eyedrop

Study type: Interventional

Funder types: Other

Identifiers

NCT06163989

HLS21135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: TheaLoz Duo Eyedrop

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

Active Comparator group

Description:

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.

Treatment:

Drug: TheaLoz Duo Eyedrop