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Protecting the Eyes of Gamers With Lubricating Eyedrops

Study acronym: PROTEGE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary and study completion dates: Dec 30, 2025 to Dec 30, 2026v7
  2. Notable Primary completion date: Dec 30, 2024 to Dec 30, 2025
    • Study completion date: Feb 28, 2025 to Dec 30, 2025
    v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v5
  4. Minor Interventions: Saline Eyedrop (Drug), TheaLoz Duo Eyedrop (Drug) to TheaLoz Duo Eyedrop (Drug)v4
  5. Notable Start date: May 1, 2024 to Sep 1, 2024
    • Primary completion date: Jul 30, 2024 to Dec 30, 2024
    • Study completion date: Aug 31, 2024 to Feb 28, 2025
    • Eligibility criteria shortened, about 24 words
    v3
  6. Notable Start date: Feb 1, 2024 to May 1, 2024v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06163989
Lead Sponsor Aston University
Conditions
(from sponsor)
Dry Eye Syndromes, Computer Vision Syndrome
Related terms Dry Eye Syndromes
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov