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Moisture Chamber Glasses for Dry Eye in Asian Population

Sponsor
Singapore National Eye Centre (Other)
Overall Status
Completed
CT.gov ID
NCT01388426
Collaborator
(none)
11
Enrollment
2
Locations
1
Arm
13
Duration (Months)
5.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 7eye( Panoptx)™ moisture chamber glasses
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Moisture Chamber Glasses for Dry Eye in Asian Population
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 7eye( Panoptx)™ Moisture chamber glasses

7eye( Panoptx)™

Device: 7eye( Panoptx)™ moisture chamber glasses
moisture chamber glasses
Other Names:
  • 7eye™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study. [2 weeks during 3 months]

    Secondary Outcome Measures

    1. 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). [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. Subjects who can't wear the eye wear as instructed in the study, or unable to complete the diary of eye wear use.

    2. Subjects with eye lid or facial bone malformation

    3. Subjects with a significant refractive error that warrants spectacles with a refractive power.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Singapore National Eye Center Singapore Singapore 168751
    2 Singapore National Eye Centre Singapore Singapore 168751

    Sponsors and Collaborators

    • Singapore National Eye Centre

    Investigators

    • Principal Investigator: Samanthila Waduthantri, Singapore National Eye Centre
    • Principal Investigator: Louis Tong, Singapore National Eye Centre
    • Study Chair: Chien Hua Tan, Singapore National Eye Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samanthila Waduthantri, Clinical Research Fellow, Clinical Associate, Singapore National Eye Centre
    ClinicalTrials.gov Identifier:
    NCT01388426
    Other Study ID Numbers:
    • R746
    First Posted:
    Jul 6, 2011
    Last Update Posted:
    Jan 10, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca

    Study Results

    No Results Posted as of Jan 10, 2013