Impact of Tear Substitute Use on Dry Eye in Gamers.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dry Eye and Digital Asthenopia Signs and Symptoms in Gaming Adults. Impact of Tear Substitute Use.

Conditions
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Evaporative Dry Eye

Intervention / Treatment
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* Other: Preservative free hyaluronic acid artificial tear


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Preservative free Hyaluronic acid 0.15% artificial tear instilled in both eyes 4 times daily for 3 days | Other: Preservative free hyaluronic acid artificial tear<br>* Ocular lubricant<br>|
| No Intervention: Control group<br>No artificial tear instilation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Between Day 1 and Day 3 | 
| Tear Breakup Time (TBUT) | Change in Tear Breakup Time (TBUT) score (normal values > or equal to 10 seconds) between study and control group | Between Day 1 and Day 3 | 
| 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 | Between Day 1 and Day 3 | 
| 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 | Between Day 1 and Day 3 | 
| Schirmer I tear volume test | Change in Schirmer score (normal values equal or higher than 10) between study and control group | Between Day 1 and Day 3 | 
| Near convergence measured with a RAF binocular gauge | Change in near convergence between study and control group | Between Day 1 and Day 3 | 
| Accomodation distance measured with a RAF binocular gauge | Change in accomodation distance between study and control group | Between Day 1 and Day 3 |