Dry EyeBURNABYNCT01611922
Optimization of Assessment and Grading for Lid Wiper Epitheliopathy
An observational study of Dry Eye, run by Alcon Research at 1 site in Canada.
Trial summary
The purpose of this study is to assess eyelid margin staining, termed "lid wiper epitheliopathy" (LWE), in three populations. The hypothesis is LWE will be more prevalent in symptomatic contact lens wearers than non-symptomatic contact lens wearers and least prevalent in asymptomatic non-contact lens wearers. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Ophthalmic dye and Contact lenses
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to May 2012
- Phase
- Observational
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be identified and screened by the University of Waterloo in Ontario, Canada.
Who may be able to join
- Has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has had an ocular examination in the last two years;
- Has clear corneas and no active ocular disease;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Has any ocular disease;
- Has a systemic condition that may affect a study outcome variable;
- Is using any systemic or topical medications that may affect ocular health;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Has undergone corneal refractive surgery;
- Currently wears contact lenses on an extended wear basis (overnight);
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo
Waterloo, N2L 3G1
About this study
The purpose of this study is to assess eyelid margin staining, termed "lid wiper epitheliopathy" (LWE), in three populations. The hypothesis is LWE will be more prevalent in symptomatic contact lens wearers than non-symptomatic contact lens wearers and least prevalent in asymptomatic non-contact lens wearers.
- Conditions
- Dry Eye
- Being tested
- Ophthalmic dye, Contact lenses
- Keywords
- eye, eyelid, contact lenses, dry eye disease
- 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.
Ophthalmic dyeOther
Also called Lissamine Green, Sodium Fluorescein
Topically instilled for the purpose of assessing lid margin staining
Contact lensesDevice
Silicone hydrogel contact lenses per subject's habitual brand and power, worn for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic Lens Wearers | Contact lens wearers reporting a habitual wear time of less than eight hours and a noticeable reduction in comfort over a wearing day Receives: Other: Ophthalmic dye; Device: Contact lenses | |
| Non-Symptomatic Contact Lens Wearers | Contact lens wearers reporting a comfortable wear time of more than 10 hours and minimal reduction in comfort over a wearing day Receives: Other: Ophthalmic dye; Device: Contact lenses | |
| Asymptomatic Non-Contact Lens Wearers | Non-contact lens wearers reporting a minimal reduction in ocular comfort over the course of a day Receives: Other: Ophthalmic dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
LWE-associated staining score
Lens wearers must wear lenses for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled. LWE-associated staining will be assessed by the investigator and reported as a composite score based on Korb's method.
Measured: 3 minutes after dye instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2012
- Study completionMay 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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, FCOptom, PhD, Principal investigator, Centre for Contact Lens Research, School of Optometry, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611922
- Sponsor's protocol ID
- P/365/11/L
- Acronym
- BURNABY
- Status last verified
- Jun 2012
- First submitted
- 31 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Assessment and Grading for Lid Wiper Epitheliopathy
- ClinicalTrials.gov ID
- NCT01611922
- Acronym / sponsor ID
- BURNABY / P/365/11/L
- Conditions
- Dry Eye
- Keywords
- eye, eyelid, contact lenses, dry eye disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Jun 2012 (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.
The purpose of this study is to assess eyelid margin staining, termed "lid wiper epitheliopathy" (LWE), in three populations. The hypothesis is LWE will be more prevalent in symptomatic contact lens wearers than non-symptomatic contact lens wearers and least prevalent in asymptomatic non-contact lens wearers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Lens Wearers | – | Other: Ophthalmic dye, Device: Contact lensesContact lens wearers reporting a habitual wear time of less than eight hours and a noticeable reduction in comfort over a wearing day |
| Non-Symptomatic Contact Lens Wearers | – | Other: Ophthalmic dye, Device: Contact lensesContact lens wearers reporting a comfortable wear time of more than 10 hours and minimal reduction in comfort over a wearing day |
| Asymptomatic Non-Contact Lens Wearers | – | Other: Ophthalmic dyeNon-contact lens wearers reporting a minimal reduction in ocular comfort over the course of a day |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be identified and screened by the University of Waterloo in Ontario, Canada.
Key inclusion criteria (6 listed)
- Has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has had an ocular examination in the last two years;
- Has clear corneas and no active ocular disease;
Key exclusion criteria (8 listed)
- Has any ocular disease;
- Has a systemic condition that may affect a study outcome variable;
- Is using any systemic or topical medications that may affect ocular health;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Has undergone corneal refractive surgery;
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 |
|---|---|---|
| Ophthalmic dyeAlso: Lissamine Green, Sodium FluoresceinTopically instilled for the purpose of assessing lid margin staining | Other | Asymptomatic Non-Contact Lens Wearers, Non-Symptomatic Contact Lens Wearers, Symptomatic Lens Wearers |
| Contact lensesSilicone hydrogel contact lenses per subject's habitual brand and power, worn for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled. | Device | Non-Symptomatic Contact Lens Wearers, Symptomatic Lens Wearers |
Primary outcome
LWE-associated staining score
Time frame: 3 minutes after dye instillation
Lens wearers must wear lenses for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled. LWE-associated staining will be assessed by the investigator and reported as a composite score based on Korb's method.
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 5 Jun 2012.
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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.
Lyndon Jones, FCOptom, PhD principal investigator
Centre for Contact Lens Research, School of Optometry, University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Alcon Research at 1 site in Canada.
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 6 inclusion and 8 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 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
LWE-associated staining score (time frame: 3 minutes after dye instillation). 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 5 Jun 2012.