Moisture Chamber Glasses for Dry Eye in Asian Population

January 8, 2013 updated by: Samanthila Waduthantri, Singapore National Eye Centre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168751
        • Singapore National Eye Centre
      • Singapore, Singapore, 168751
        • Singapore National Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 7eye( Panoptx)™ Moisture chamber glasses
7eye( Panoptx)™
Device: 7eye( Panoptx)™ moisture chamber glasses
moisture chamber glasses
Other Names:
  • 7eye™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study.
Time Frame: 2 weeks during 3 months
2 weeks during 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

July 1, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R746

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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