Moisture Chamber Glasses for Dry Eye in Asian Population
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
7eye( Panoptx)™ moisture chamber glasses
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
1. Subjects with evaporative dry eye as assessed by the PI in the dry eye clinic and has occupational or lifestyle requirement to be exposed to a hyper-evaporative environment.
Exclusion Criteria:
- Subjects who can't wear the eye wear as instructed in the study, or unable to complete the diary of eye wear use.
- Subjects with eye lid or facial bone malformation
- Subjects with a significant refractive error that warrants spectacles with a refractive power.
Sites / Locations
- Singapore National Eye Center
- Singapore National Eye Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
7eye( Panoptx)™ Moisture chamber glasses
Arm Description
7eye( Panoptx)™
Outcomes
Primary Outcome Measures
Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study.
Secondary Outcome Measures
1.Number of eyedrops per day for each type of medication used at the end of study vs at the commencement of study,symptoms of dry eye (using the VAS),corneal fluorescence staining and tear break up time(TBUT).
Full Information
NCT ID
NCT01388426
First Posted
June 28, 2011
Last Updated
January 8, 2013
Sponsor
Singapore National Eye Centre
1. Study Identification
Unique Protocol Identification Number
NCT01388426
Brief Title
Moisture Chamber Glasses for Dry Eye in Asian Population
Official Title
Moisture Chamber Glasses for Dry Eye in Asian Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore National Eye Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objective of this study is to evaluate the tolerance and potential benefit of moisture chamber glasses for dry eye in an Asian population. In this clinic based prospective interventional study, we aim to recruit patients (until 10 patients complete the study) who have evaporative dry eye due to exposure to environmental stress (such as frequency of out door activities) and keen to try out moisture chamber glasses/ eyewear from the dry eye clinic in Singapore National Centre. After informed consent, these patients will be prescribed 7eye( Panoptx)™ moisture chamber glasses/eyewear for 3 months and will be monitored on a diary for the amount of time wearing eyewear for 2 weeks and the number of eye drops for each type of medication used. Other outcomes will be changes in symptoms of dry eye using visual analog scale, as well as objective signs of dry eye (eg. corneal fluorescence staining and tear break up time (TBUT). As moisture chamber spectacles are currently not available as a treatment option for dry eye in Singapore, the findings of this study will give an insight to the efficacy of this new treatment modality in our population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
7eye( Panoptx)™ Moisture chamber glasses
Arm Type
Experimental
Arm Description
7eye( Panoptx)™
Intervention Type
Device
Intervention Name(s)
7eye( Panoptx)™ moisture chamber glasses
Other Intervention Name(s)
7eye™
Intervention Description
moisture chamber glasses
Primary Outcome Measure Information:
Title
Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study.
Time Frame
2 weeks during 3 months
Secondary Outcome Measure Information:
Title
1.Number of eyedrops per day for each type of medication used at the end of study vs at the commencement of study,symptoms of dry eye (using the VAS),corneal fluorescence staining and tear break up time(TBUT).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Subjects with evaporative dry eye as assessed by the PI in the dry eye clinic and has occupational or lifestyle requirement to be exposed to a hyper-evaporative environment.
Exclusion Criteria:
Subjects who can't wear the eye wear as instructed in the study, or unable to complete the diary of eye wear use.
Subjects with eye lid or facial bone malformation
Subjects with a significant refractive error that warrants spectacles with a refractive power.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samanthila Waduthantri
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Louis Tong
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chien Hua Tan
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Singapore National Eye Center
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
12. IPD Sharing Statement
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Moisture Chamber Glasses for Dry Eye in Asian Population
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