Moisture Chamber Glasses for Dry Eye in Asian Population
This study has been completed.
Sponsor:
Singapore National Eye Centre
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
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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:
Genetics Home Reference related topics:
keratitis-ichthyosis-deafness syndrome
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 (Adult, Senior) |
| 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
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
| 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 |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs |
Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on September 23, 2016