Moisture Chamber Glasses for Dry Eye in Asian Population

NCT01388426 | Completed DMC

• 1 other identifier: R746
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study.

  2 weeks during 3 months

Secondary Outcomes (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

Study Arms (1)

7eye( Panoptx)™ Moisture chamber glasses

EXPERIMENTAL

7eye( Panoptx)™

Device: 7eye( Panoptx)™ moisture chamber glasses

Interventions

7eye( Panoptx)™ moisture chamber glasses DEVICE

moisture chamber glasses

Also known as: 7eye™

7eye( Panoptx)™ Moisture chamber glasses

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (2)

Singapore National Eye Center

Singapore, Singapore, 168751, Singapore

Location

Singapore National Eye Centre

Singapore, Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Samanthila Waduthantri

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

• Louis Tong

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

• Chien Hua Tan

  Singapore National Eye Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow, Clinical Associate

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 6, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

SG (2)