Back to resultsImpact of Tear Substitute Use on Dry Eye in Gamers. (HYAGAME)
Primary Purpose
Evaporative Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Preservative free hyaluronic acid artificial tear
Sponsored by
About this trial
This is an interventional treatment trial for Evaporative Dry Eye
Eligibility Criteria
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- Ocular, nasolagrimal or palpebral active condition different from dry eye disease.
- History of ocular trauma or infecction in the last 3 months previous to inclusion.
- History of refractive surgery.
- Visual acuity 0.5 or less in at least 1 eye.
- Ocular medication use in the 3 days prior to inclusion.
- 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.
Sites / Locations
- Dreamhack Convention
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group
Control group
Arm Description
Preservative free Hyaluronic acid 0.15% artificial tear instilled in both eyes 4 times daily for 3 days
No artificial tear instilation
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Conjunctival hyperemia measured with McMonnies Chapman scale
Change in McMonnies Chapman score (range 0-5, with higher scores indicative of more conjunctival hyperemia) between study and control group
Tear Breakup Time (TBUT)
Change in Tear Breakup Time (TBUT) score (normal values > or equal to 10 seconds) between study and control group
Conjunctival staining with lisamine green measured with Oxford scale
Change in conjunctival oxford staining score (range 0-5 with higher scores indicative of more staining) between study and control group
Corneal staining with fluorescein measured with Oxford scale
Change in corneal oxford staining score (range 0-5 with higher scores indicative of more staining) between study and control group
Schirmer I tear volume test
Change in Schirmer score (normal values equal or higher than 10) between study and control group
Near convergence measured with a RAF binocular gauge
Change in near convergence between study and control group
Accomodation distance measured with a RAF binocular gauge
Change in accomodation distance between study and control group
Full Information
NCT ID
NCT05536661
First Posted
September 7, 2022
Last Updated
September 9, 2022
Sponsor
Laboratorios Thea, Spain
Collaborators
Crossdata
1. Study Identification
Unique Protocol Identification Number
NCT05536661
Brief Title
Impact of Tear Substitute Use on Dry Eye in Gamers.
Acronym
HYAGAME
Official Title
Dry Eye and Digital Asthenopia Signs and Symptoms in Gaming Adults. Impact of Tear Substitute Use.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
July 7, 2019 (Actual)
Study Completion Date
July 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Thea, Spain
Collaborators
Crossdata
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Adult attendees to a Gamers convention will complete questionnairs and undergo an opthalmological evaluation before and after playing for 3 days in a row. Participants will be randomized into 2 groups of equal size:
Study group.
Control group. The Study group will instill hyaluronic acid 0.15% artificial tears in both eyes 4 times a day during the 3 days of the video game session, while the control group will not instill artificial tears.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaporative Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Preservative free Hyaluronic acid 0.15% artificial tear instilled in both eyes 4 times daily for 3 days
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No artificial tear instilation
Intervention Type
Other
Intervention Name(s)
Preservative free hyaluronic acid artificial tear
Intervention Description
Ocular lubricant
Primary Outcome Measure Information:
Title
Standard Patient Evaluation of Eye Dryness (SPEED)
Description
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)
Time Frame
Between Day 1 and Day 3
Secondary Outcome Measure Information:
Title
Conjunctival hyperemia measured with McMonnies Chapman scale
Description
Change in McMonnies Chapman score (range 0-5, with higher scores indicative of more conjunctival hyperemia) between study and control group
Time Frame
Between Day 1 and Day 3
Title
Tear Breakup Time (TBUT)
Description
Change in Tear Breakup Time (TBUT) score (normal values > or equal to 10 seconds) between study and control group
Time Frame
Between Day 1 and Day 3
Title
Conjunctival staining with lisamine green measured with Oxford scale
Description
Change in conjunctival oxford staining score (range 0-5 with higher scores indicative of more staining) between study and control group
Time Frame
Between Day 1 and Day 3
Title
Corneal staining with fluorescein measured with Oxford scale
Description
Change in corneal oxford staining score (range 0-5 with higher scores indicative of more staining) between study and control group
Time Frame
Between Day 1 and Day 3
Title
Schirmer I tear volume test
Description
Change in Schirmer score (normal values equal or higher than 10) between study and control group
Time Frame
Between Day 1 and Day 3
Title
Near convergence measured with a RAF binocular gauge
Description
Change in near convergence between study and control group
Time Frame
Between Day 1 and Day 3
Title
Accomodation distance measured with a RAF binocular gauge
Description
Change in accomodation distance between study and control group
Time Frame
Between Day 1 and Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
Ocular, nasolagrimal or palpebral active condition different from dry eye disease.
History of ocular trauma or infecction in the last 3 months previous to inclusion.
History of refractive surgery.
Visual acuity 0.5 or less in at least 1 eye.
Ocular medication use in the 3 days prior to inclusion.
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.
Facility Information:
Facility Name
Dreamhack Convention
City
Valencia
ZIP/Postal Code
46035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Tear Substitute Use on Dry Eye in Gamers.
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