Impact of Tear Substitute Use on Dry Eye in Gamers.

Not Applicable

Completed

• Conditions: Evaporative Dry Eye

• Registration Number: NCT05536661
• Lead Sponsor: Laboratorios Thea, Spain

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:

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 Timeline

• Study Start: 2019-07-04
• Primary Completion: 2019-07-07
• Study Completion: 2019-07-07
• Status Verified: 2022-09
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Study First Posted: 2022-09-13
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Standard Patient Evaluation of Eye Dryness (SPEED)	Between Day 1 and Day 3	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

Name	Time	Method
Tear Breakup Time (TBUT)	Between Day 1 and Day 3	Change in Tear Breakup Time (TBUT) score (normal values \> or equal to 10 seconds) between study and control group
Accomodation distance measured with a RAF binocular gauge	Between Day 1 and Day 3	Change in accomodation distance between study and control group
Conjunctival staining with lisamine green measured with Oxford scale	Between Day 1 and Day 3	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	Between Day 1 and Day 3	Change in corneal oxford staining score (range 0-5 with higher scores indicative of more staining) between study and control group
Near convergence measured with a RAF binocular gauge	Between Day 1 and Day 3	Change in near convergence between study and control group
Conjunctival hyperemia measured with McMonnies Chapman scale	Between Day 1 and Day 3	Change in McMonnies Chapman score (range 0-5, with higher scores indicative of more conjunctival hyperemia) between study and control group
Schirmer I tear volume test	Between Day 1 and Day 3	Change in Schirmer score (normal values equal or higher than 10) between study and control group

Trial Locations

Locations (1)

Dreamhack Convention; 🇪🇸 Valencia, Spain