Evaporative Dry EyeHYAGAMENCT05536661
Impact of Tear Substitute Use on Dry Eye in Gamers.
A study testing Preservative free hyaluronic acid artificial tear in people with Evaporative Dry Eye, run by Laboratorios Thea, Spain at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaporative Dry Eye
- What is being tested?
- Preservative free hyaluronic acid artificial tear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jul 2019to 7 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Use of systemic medication known to induce dry eye in the last 30 days.
- Known allergy to hyaluronic acid.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Study group.
- 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
- Evaporative Dry Eye
- Being tested
- Preservative free hyaluronic acid artificial tear
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative free hyaluronic acid artificial tearOther
Ocular lubricant
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Preservative free Hyaluronic acid 0.15% artificial tear instilled in both eyes 4 times daily for 3 days Receives: Other: Preservative free hyaluronic acid artificial tear |
| Control group | No intervention | No artificial tear instilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Between Day 1 and Day 3
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Between Day 1 and Day 3
Near convergence measured with a RAF binocular gauge
Change in near convergence between study and control group
Measured: Between Day 1 and Day 3
Accomodation distance measured with a RAF binocular gauge
Change in accomodation distance between study and control group
Measured: Between Day 1 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start4 Jul 2019
- Primary completion7 Jul 2019
- Study completion7 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaporative Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Thea, Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Crossdata
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536661
- Sponsor's protocol ID
- THEA-HYA-GAMERS-2019-01
- Acronym
- HYAGAME
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Eye and Digital Asthenopia Signs and Symptoms in Gaming Adults. Impact of Tear Substitute Use.
- ClinicalTrials.gov ID
- NCT05536661
- Acronym / sponsor ID
- HYAGAME / THEA-HYA-GAMERS-2019-01
- Conditions
- Evaporative Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Laboratorios Thea, SpainIndustry (pharma, biotech, devices)
- Collaborators
- Crossdata
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 7 Jul 2019 (actual)
- Study completion
- 7 Jul 2019 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Study group.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Preservative free hyaluronic acid artificial tearPreservative free Hyaluronic acid 0.15% artificial tear instilled in both eyes 4 times daily for 3 days |
| Control group | No intervention | –No artificial tear instilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preservative free hyaluronic acid artificial tearOcular lubricant | Other | Study group |
Primary outcome
Standard Patient Evaluation of Eye Dryness (SPEED)
Time frame: 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)
7 secondary outcomes
Conjunctival hyperemia measured with McMonnies Chapman scale
Time frame: Between Day 1 and Day 3
Tear Breakup Time (TBUT)
Time frame: Between Day 1 and Day 3
Conjunctival staining with lisamine green measured with Oxford scale
Time frame: Between Day 1 and Day 3
Corneal staining with fluorescein measured with Oxford scale
Time frame: Between Day 1 and Day 3
Schirmer I tear volume test
Time frame: Between Day 1 and Day 3
Near convergence measured with a RAF binocular gauge
Time frame: Between Day 1 and Day 3
Accomodation distance measured with a RAF binocular gauge
Time frame: Between Day 1 and Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Evaporative Dry Eye
Not yet recruitingPhase 4
Evaporative Dry Eye
Dry Eye, Evaporative Dry Eye
Active, not recruitingObservational study
Study for Remote Investigation of Evaporative Dry Eye Disease
Evaporative Loss Dry Eye Disease
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Active, not recruiting
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
Evaporative Dry Eye
Not yet recruiting
Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
Dry Eye Disease, Dry Eye
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preservative free hyaluronic acid artificial tear in people with Evaporative Dry Eye, run by Laboratorios Thea, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Patient Evaluation of Eye Dryness (SPEED) (time frame: Between Day 1 and Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.