Impact of Tear Substitute Use on Dry Eye in Gamers.

Evaporative Dry Eye Clinical Trial

— HYAGAME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05536661
• Other study ID #: THEA-HYA-GAMERS-2019-01
• Status: Completed
• Phase: N/A
• Start date: July 4, 2019
• Est. completion date: July 7, 2019

Study information

• Verified date: September 2022
• Source: Laboratorios Thea, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 7, 2019
• Est. primary completion date: July 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Evaporative Dry Eye
• Keratoconjunctivitis Sicca

Intervention

Other:
• Preservative free hyaluronic acid artificial tear
Ocular lubricant

Locations

Country	Name	City	State
Spain	Dreamhack Convention	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Thea, Spain	Crossdata

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Near convergence measured with a RAF binocular gauge	Change in near convergence between study and control group	Between Day 1 and Day 3
Secondary	Accomodation distance measured with a RAF binocular gauge	Change in accomodation distance between study and control group	Between Day 1 and Day 3