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

History of Changes

Purpose

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	Intervention
Dry Eye	Device: 7eye( Panoptx)™ moisture chamber glasses


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Moisture Chamber Glasses for Dry Eye in Asian Population

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:

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 ]

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). [ Time Frame: 3 months ] [ Designated as safety issue: No ]


Enrollment:	11
Study Start Date:	July 2011
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 7eye( Panoptx)™ Moisture chamber glasses 7eye( Panoptx)™	Device: 7eye( Panoptx)™ moisture chamber glasses moisture chamber glasses Other Name: 7eye™

Eligibility


Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
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:

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.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01388426

Locations


Singapore
Singapore National Eye Center
Singapore, Singapore, 168751
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

More Information

No publications provided


Responsible Party:	Samanthila Waduthantri, Clinical Research Fellow, Clinical Associate, Singapore National Eye Centre
ClinicalTrials.gov Identifier:	NCT01388426 History of Changes
Other Study ID Numbers:	R746
Study First Received:	June 28, 2011
Last Updated:	January 8, 2013
Health Authority:	SingHealth Centralised Institutional Review Board: Singapore

ClinicalTrials.gov processed this record on March 03, 2015

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