Dry EyeNCT01388426
Moisture Chamber Glasses for Dry Eye in Asian Population
A study testing 7eye( Panoptx)™ moisture chamber glasses in people with Dry Eye, run by Singapore National Eye Centre at 2 sites in Singapore.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- 7eye( Panoptx)™ moisture chamber glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesSingapore
- Study dates
- Jul 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore National Eye Center
Singapore, Singapore, 168751
Singapore National Eye Centre
Singapore, Singapore, 168751
About this study
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
- Being tested
- 7eye( Panoptx)™ moisture chamber glasses
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7eye( Panoptx)™ moisture chamber glassesDevice
Also called 7eye™
moisture chamber glasses
| Study group | Role | What they receive |
|---|---|---|
| 7eye( Panoptx)™ Moisture chamber glasses | Experimental | 7eye( Panoptx)™ Receives: Device: 7eye( Panoptx)™ moisture chamber glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study.
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Samanthila Waduthantri, Singapore National Eye Centre
- Investigators
- Samanthila Waduthantri, Principal investigator, Singapore National Eye CentreLouis Tong, Principal investigator, Singapore National Eye CentreChien Hua Tan, Study chair, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388426
- Sponsor's protocol ID
- R746
- Status last verified
- Jan 2013
- First submitted
- 28 Jun 2011
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moisture Chamber Glasses for Dry Eye in Asian Population
- ClinicalTrials.gov ID
- NCT01388426
- Acronym / sponsor ID
- R746
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7eye( Panoptx)™ Moisture chamber glasses | Experimental | Device: 7eye( Panoptx)™ moisture chamber glasses7eye( Panoptx)™ |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7eye( Panoptx)™ moisture chamber glassesAlso: 7eye™moisture chamber glasses | Device | 7eye( Panoptx)™ Moisture chamber glasses |
Primary outcome
Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study.
Time frame: 2 weeks during 3 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samanthila Waduthantri principal investigator
Singapore National Eye Centre
Louis Tong principal investigator
Singapore National Eye Centre
Chien Hua Tan study chair
Singapore National Eye Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7eye( Panoptx)™ moisture chamber glasses in people with Dry Eye, run by Singapore National Eye Centre at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study. (time frame: 2 weeks during 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.