Moisture Chamber Glasses for Dry Eye in Asian Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samanthila Waduthantri, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01388426
First received: June 28, 2011
Last updated: January 8, 2013
Last verified: January 2013

June 28, 2011
January 8, 2013
July 2011
August 2012   (final data collection date for primary outcome measure)
Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study. [ Time Frame: 2 weeks during 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01388426 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Moisture Chamber Glasses for Dry Eye in Asian Population
Moisture Chamber Glasses for Dry Eye in Asian Population

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dry Eye
Device: 7eye( Panoptx)™ moisture chamber glasses
moisture chamber glasses
Other Name: 7eye™
Experimental: 7eye( Panoptx)™ Moisture chamber glasses
7eye( Panoptx)™
Intervention: Device: 7eye( Panoptx)™ moisture chamber glasses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01388426
R746
Yes
Samanthila Waduthantri, Singapore National Eye Centre
Singapore National Eye Centre
Not Provided
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
Singapore National Eye Centre
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP