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Moisture Chamber Glasses for Dry Eye in Asian Population

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ClinicalTrials.gov Identifier: NCT01388426
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
Samanthila Waduthantri, Singapore National Eye Centre

Study Description
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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
Dry Eye Device: 7eye( Panoptx)™ moisture chamber glasses Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : July 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: 7eye( Panoptx)™ Moisture chamber glasses
7eye( Panoptx)™
 Device: 7eye( Panoptx)™ moisture chamber glasses
moisture chamber glasses
Other Name: 7eye™


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study. [ Time Frame: 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). [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388426


Locations
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Singapore
Singapore National Eye Center
Singapore, Singapore, 168751
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
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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
More Information
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Responsible Party: Samanthila Waduthantri, Clinical Research Fellow, Clinical Associate, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01388426    
Other Study ID Numbers: R746
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases