Dry EyeNCT03840668
Healthy Living Through Personalized Monitoring of Eyelid Care
A study testing USB Eye Mask in people with Dry Eye, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- USB Eye Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Mar 2024to 20 Feb 2025
- 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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be 21 years or older.
- Subject must have severe MGD
- Subject must be willing to answer the questions in the questionnaire
- Subject must be willing to use the USB-powered eyemask as instructed
- Subject must have the ability to provide informed consent
- Subject must be willing to come back for follow-up visit
Who cannot join
- Any other specified reason as determined by the clinical investigator.
- Is pregnant, lactating or planning a pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period.
Read the detailed description
Dry eye is a very common condition that can cause blurring of vision associated with reading, grittiness, eyelid heaviness and poor tolerance of light. Up to 80% of dry eye is due to blocked oil glands in the eyelids known as Meibomian Gland Dysfunction (MGD) and scientific studies have shown that sustained eyelid warming at 40-42°C for at least 8 minutes a day is effective to control this condition and increase the tear film layer thickness.
Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period. To further encourage eyelid warming to be performed more frequently, the signal can also be sent to a participating games server which hastens progress in the game. Thus, addiction to online games, which usually worsens symptoms of dry eye can now be a way to treat dry eye.
- Conditions
- Dry Eye
- Being tested
- USB Eye Mask
- Keywords
- USB eyemask
- 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.
USB Eye MaskDevice
To evaluate the acceptance of the USB eye mask via questionnaire and also to monitor the use of USB eye mask over a period of 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Dry eye | Experimental | Participants who will be using the USB-powered eye mask. Receives: Device: USB Eye Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of USB eyemask questionnaire
Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask
Measured: 2 months +/-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start18 Mar 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Ngee Ann Polytechnic Singapore
- Responsible party
- Principal investigator, Louis Tong, Singapore National Eye Centre
- Investigators
- Louis Tong, PhD, Principal investigator, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840668
- Sponsor's protocol ID
- R1507/6/2018
- Other IDs
- 2018/2102
- Status last verified
- May 2025
- First submitted
- 3 Dec 2018
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Living Through Personalized Monitoring of Eyelid Care
- ClinicalTrials.gov ID
- NCT03840668
- Acronym / sponsor ID
- R1507/6/2018
- Conditions
- Dry Eye
- Keywords
- USB eyemask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Ngee Ann Polytechnic Singapore
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 15 Feb 2019 (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.
Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period.
Detailed description
Dry eye is a very common condition that can cause blurring of vision associated with reading, grittiness, eyelid heaviness and poor tolerance of light. Up to 80% of dry eye is due to blocked oil glands in the eyelids known as Meibomian Gland Dysfunction (MGD) and scientific studies have shown that sustained eyelid warming at 40-42°C for at least 8 minutes a day is effective to control this condition and increase the tear film layer thickness.
Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period. To further encourage eyelid warming to be performed more frequently, the signal can also be sent to a participating games server which hastens progress in the game. Thus, addiction to online games, which usually worsens symptoms of dry eye can now be a way to treat dry eye.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry eye | Experimental | Device: USB Eye MaskParticipants who will be using the USB-powered eye mask. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be 21 years or older.
- Subject must have severe MGD
- Subject must be willing to answer the questions in the questionnaire
- Subject must be willing to use the USB-powered eyemask as instructed
- Subject must have the ability to provide informed consent
Key exclusion criteria (2 listed)
- Any other specified reason as determined by the clinical investigator.
- Is pregnant, lactating or planning a pregnancy.
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 |
|---|---|---|
| USB Eye MaskTo evaluate the acceptance of the USB eye mask via questionnaire and also to monitor the use of USB eye mask over a period of 2 months. | Device | Dry eye |
Primary outcome
Acceptance of USB eyemask questionnaire
Time frame: 2 months +/-14 days
Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask
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 15 May 2025.
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Louis Tong, PhD principal investigator
Singapore Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USB Eye Mask in people with Dry Eye, run by Singapore National Eye Centre at 1 site in Singapore.
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 6 inclusion and 2 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 15 May 2025. 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 Singapore. 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?
Acceptance of USB eyemask questionnaire (time frame: 2 months +/-14 days). 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 15 May 2025.