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Healthy Living Through Personalized Monitoring of Eyelid Care

Primary Purpose

Dry Eye

Status
Not yet recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
USB Eye Mask
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dry Eye focused on measuring USB eyemask

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects must be 21 years or older.
  2. Subject must have severe MGD
  3. Subject must be willing to answer the questions in the questionnaire
  4. Subject must be willing to use the USB-powered eyemask as instructed
  5. Subject must have the ability to provide informed consent
  6. Subject must be willing to come back for follow-up visit

Exclusion Criteria:

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

Sites / Locations

  • Singapore Eye Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dry eye

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2018
Last Updated
October 17, 2023
Sponsor
Singapore National Eye Centre
Collaborators
Ngee Ann Polytechnic Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03840668
Brief Title
Healthy Living Through Personalized Monitoring of Eyelid Care
Official Title
Healthy Living Through Personalized Monitoring of Eyelid Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore National Eye Centre
Collaborators
Ngee Ann Polytechnic Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
USB eyemask

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry eye
Arm Type
Experimental
Arm Description
Participants who will be using the USB-powered eye mask.
Intervention Type
Device
Intervention Name(s)
USB Eye Mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptance of USB eyemask questionnaire
Description
Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask
Time Frame
2 months +/-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Any other specified reason as determined by the clinical investigator. Is pregnant, lactating or planning a pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louis Tong, PhD
Phone
65767200
Email
louis.tong.h.t@singhealth.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Yeo, BSc
Phone
65767200
Email
sharon.yeo.w.j@seri.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Tong, PhD
Organizational Affiliation
Singapore Eye Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
169856
Country
Singapore

12. IPD Sharing Statement

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Healthy Living Through Personalized Monitoring of Eyelid Care

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