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.

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.

Study Overview

• Status: Completed
• Conditions: Evaporative Dry Eye
• Intervention / Treatment: Other: Preservative free hyaluronic acid artificial tear

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:

1. Study group.
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46035
    • Dreamhack Convention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; 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; Ocular lubricant
No Intervention: Control group; No artificial tear instilation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratorios Thea, Spain
• Collaborators: Crossdata

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2019
• Primary Completion (Actual): July 7, 2019
• Study Completion (Actual): July 7, 2019

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Pharmaceutical Solutions; Viscosupplements; Ophthalmic Solutions; Hyaluronic Acid; Lubricant Eye Drops
• Other Study ID Numbers: THEA-HYA-GAMERS-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No