Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06163989

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

Led by Aston University · Updated on 2026-01-21

28

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Digital gamers who use handheld consoles and computers often experience damage and symptoms related to dryness of the eye surface due to excessive screen time. This research evaluates whether a lubricating eyedrop called TheaLoz Duo can protect the eye surface from dryness and relieve symptoms of dry eye disease in this population. The study is a randomized, outcome assessor-masked, cross-over clinical trial conducted at Aston University to address this growing concern among gamers worldwide. Participants will use TheaLoz Duo eyedrops containing trehalose and sodium hyaluronate four times daily for one month during one treatment period, and have no eyedrops during the other month. They will be assigned randomly to start either with the eyedrop or the control (no eyedrops) for one month, then switch to the other condition for the following month. The study includes three visits spaced one month apart, during which clinical assessments will be performed. During each visit, participants will undergo routine examinations of the front of the eye to monitor symptoms and signs of dry eye disease. Measurements will include changes in Ocular Surface Disease Index scores and other eye health indicators over the two months. Participants must be able to apply the eyedrops themselves and attend all three visits. The study aims to provide valuable data to improve eye care for gamers by carefully tracking multiple eye health outcomes and symptoms throughout the study period.

CONDITIONS

Brief Title

Protecting the Eyes of Gamers With Lubricating Eyedrops

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with dry eye symptoms as shown by an Ocular Surface Disease Index score of 13 or higher
  • People who play handheld console or computer games for at least 2 hours each day on average
  • Individuals comfortable and able to use smartphone applications
  • Adults aged 18 years or older, any gender
  • Able to provide written consent in English
  • Able to apply the lubricating eyedrop themselves and return the used bottle at the end of treatment
  • Able to attend three study visits over two months
Not Eligible

You will not qualify if you...

  • Pregnant individuals
  • Use of any topical eye medications or lubricants within one week before starting or during the study; participants using lubricating eyedrops must stop them one week before starting
  • History of eye surgery, trauma, or infections within the past six months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 months

Participants use TheaLoz Duo lubricating eyedrops by instilling 1 drop, 4 times a day in both eyes for 1 month or are monitored without eyedrops, then crossover to the alternate condition for another month.

3 visits (in-person) over 2 months

Follow-up

Duration - 1 day

Participants attend a final visit after completing both treatment periods to return the eyedrop bottle and complete study assessments.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

School of Optometry, Aston University

Birmingham, West Midlands, United Kingdom, B4 7ET

Actively Recruiting

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Research Team

J

James S Wolffsohn, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A reliable and valid questionnaire was developed to measure computer vision syndrome at the workplace.

María del Mar Seguí, Julio Cabrero-García, Ana Crespo...

https://pubmed.ncbi.nlm.nih.gov/25744132