Impact of Tear Substitute Use on Dry Eye in Gamers.

NCT ID: NCT05536661

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-04

Study Completion Date

2019-07-07

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:

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.

Conditions

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Evaporative Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Study group

Preservative free Hyaluronic acid 0.15% artificial tear instilled in both eyes 4 times daily for 3 days

Group Type EXPERIMENTAL

Preservative free hyaluronic acid artificial tear

Intervention Type OTHER

Ocular lubricant

Control group

No artificial tear instilation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preservative free hyaluronic acid artificial tear

Ocular lubricant

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Crossdata

UNKNOWN

Sponsor Role collaborator

Laboratorios Thea, Spain

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dreamhack Convention

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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THEA-HYA-GAMERS-2019-01

Identifier Type: -

Identifier Source: org_study_id

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