Impact of Tear Substitute Use on Dry Eye in Gamers.
HYAGAME
Dry Eye and Digital Asthenopia Signs and Symptoms in Gaming Adults. Impact of Tear Substitute Use.
1 other identifier
interventional
56
1 country
1
Brief Summary
Clinical, prospective, comparative, controlled, single-blind study, on the signs and symptoms of dry eye before and after 3 days of playing video games with the use of artificial tears (Hyabak) versus no intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2019
CompletedFirst Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedSeptember 13, 2022
September 1, 2022
3 days
September 7, 2022
September 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Standard Patient Evaluation of Eye Dryness (SPEED)
Change in Standard Patient Evaluation of Eye Dryness (SPEED) score between study and control group (range 0-28, with higher scores indicative of dry eye disease symptoms)
Between Day 1 and Day 3
Secondary Outcomes (7)
Conjunctival hyperemia measured with McMonnies Chapman scale
Between Day 1 and Day 3
Tear Breakup Time (TBUT)
Between Day 1 and Day 3
Conjunctival staining with lisamine green measured with Oxford scale
Between Day 1 and Day 3
Corneal staining with fluorescein measured with Oxford scale
Between Day 1 and Day 3
Schirmer I tear volume test
Between Day 1 and Day 3
- +2 more secondary outcomes
Study Arms (2)
Study group
EXPERIMENTALPreservative free Hyaluronic acid 0.15% artificial tear instilled in both eyes 4 times daily for 3 days
Control group
NO INTERVENTIONNo artificial tear instilation
Interventions
Eligibility Criteria
You may qualify if:
- years or older
- Participants in videogame convention planning to play video games for a minimum of 6 hours daily for the next 3 days.
- Voluntarily accept to participate and sign informed consent form
You may not qualify if:
- Ocular, nasolagrimal or palpebral active condition different from dry eye disease.
- History of refractive surgery.
- Visual acuity 0.5 or less in at least 1 eye.
- History of systemic condition asociated to dry eye.
- Use of systemic medication known to induce dry eye in the last 30 days.
- Known allergy to hyaluronic acid.
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laboratorios Thea, Spainlead
- Crossdatacollaborator
Study Sites (1)
Dreamhack Convention
Valencia, 46035, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 13, 2022
Study Start
July 4, 2019
Primary Completion
July 7, 2019
Study Completion
July 7, 2019
Last Updated
September 13, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share