HYAGAME: Impact of Tear Substitute Use on Dry Eye in Gamers.

• Sponsor: Laboratorios Thea, Spain (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05536661
• Collaborator: Crossdata (Other)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Days): 3
• Patients Per Site Per Month: 568.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Evaporative Dry Eye	Other: Preservative free hyaluronic acid artificial tear	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: Dry Eye and Digital Asthenopia Signs and Symptoms in Gaming Adults. Impact of Tear Substitute Use.
• Actual Study Start Date: Jul 4, 2019
• Actual Primary Completion Date: Jul 7, 2019
• Actual Study Completion Date: Jul 7, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. Near convergence measured with a RAF binocular gauge [Between Day 1 and Day 3]

   Change in near convergence between study and control group

7. Accomodation distance measured with a RAF binocular gauge [Between Day 1 and Day 3]

   Change in accomodation distance between study and control group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dreamhack Convention	Valencia		Spain	46035

Sponsors and Collaborators

• Laboratorios Thea, Spain
• Crossdata

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratorios Thea, Spain
• ClinicalTrials.gov Identifier: NCT05536661
• Other Study ID Numbers: THEA-HYA-GAMERS-2019-01
• First Posted: Sep 13, 2022
• Last Update Posted: Sep 13, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Lubricant Eye Drops; Hyaluronic Acid

Study Results

No Results Posted as of Sep 13, 2022