Moisture Chamber Glasses for Dry Eye in Asian Population

Dry Eye Clinical Trial

Official title:

Moisture Chamber Glasses for Dry Eye in Asian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388426
• Other study ID #: R746
• Status: Completed
• Phase: N/A
• First received: June 28, 2011
• Last updated: January 8, 2013
• Start date: July 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: SingHealth Centralised Institutional Review Board: Singapore
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore National Eye Center	Singapore
Singapore	Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore National Eye Centre

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study.		2 weeks during 3 months	No
Secondary	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	No