NCT03840668

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
5.1 years until next milestone

Study Start

First participant enrolled

March 18, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

December 3, 2018

Last Update Submit

May 12, 2025

Conditions

Dry Eye

Keywords

USB eyemask

Outcome Measures

Primary Outcomes (1)

  • Acceptance of USB eyemask questionnaire

    Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask

    2 months +/-14 days

Study Arms (1)

Dry eye

EXPERIMENTAL

Participants who will be using the USB-powered eye mask.

Device: USB Eye Mask

Interventions

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.

Dry eye

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any other specified reason as determined by the clinical investigator.
  • Is pregnant, lactating or planning a pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Eye Research Institute

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Louis Tong, PhD

    Singapore Eye Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician-Scientist, Senior Consultant

Study Record Dates

First Submitted

December 3, 2018

First Posted

February 15, 2019

Study Start

March 18, 2024

Primary Completion

February 20, 2025

Study Completion

February 20, 2025

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations

SG(1)