MyopiaPhase 4NCT00349843
Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort
A Phase 4 study testing Soft contact lens and Marketed soft lens multipurpose disinfection regimen in people with Myopia, run by University of Waterloo at 1 site in Canada.
Trial summary
The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Soft contact lens and Marketed soft lens multipurpose disinfection regimen
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to not given
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
- Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
- Is correctable to a visual acuity of 6/6 or better with their habitual correction.
- Is willing and able to follow product usage instructions and maintain the visit schedule.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Can be successfully fitted with study lens type.
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- Has read, understood and signed an Information Consent Letter.
- Has a distance contact lens prescription is between -0.50 D and -9.00 D
- Has astigmatism of ≤ 1.00 D Cyl
- Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00D
- Has no systemic disease affecting ocular health.
- Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses.
- Has clear corneas and no active ocular disease.
- Has no known ocular or systemic allergies, which could interfere with contact lens wear.
- Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant.
- Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear.
- Has not worn extended wear contact lenses in the last 30 days.
- Has had an oculo-visual examination in the last two years
Who cannot join
- Has any active ocular disease.
- Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
- Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)
- Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
- Is using topical ocular prescription or any topical over-the-counter medication.
- Is actively involved in any other research/clinical study.
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- Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.
- Has had corneal refractive surgery.
- Has known sensitivity to any of the study solutions.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
Official title: Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort With Daily Wear FDA Group IV Hydrogel Lenses
The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.
- Conditions
- Myopia
- Being tested
- Soft contact lens, Marketed soft lens multipurpose disinfection regimen
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft contact lensDevice
Marketed soft lens multipurpose disinfection regimenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to compare corneal staining over time in
a group of individuals who wear soft contact lenses on a daily wear basis,
whilst they sequentially use two different contact lens care regimens.
Secondary outcomes (3)
The secondary objective of this study is to compare subjective ocular symptoms
over time in a group of individuals who wear soft contact lenses on a daily wear
basis, whilst they sequentially use two different contact lens care regimens.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Craig Woods, PhD, Principal investigator, University of WaterlooDesmond Fonn, MOptom, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349843
- Sponsor's protocol ID
- P/211/04/L
- Status last verified
- Dec 2015
- First submitted
- 5 Jul 2006
- Last updated
- 16 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort With Daily Wear FDA Group IV Hydrogel Lenses
- ClinicalTrials.gov ID
- NCT00349843
- Acronym / sponsor ID
- P/211/04/L
- Conditions
- Myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Jun 2005
- First posted
- 10 Jul 2006 (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 primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
- Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
- Is correctable to a visual acuity of 6/6 or better with their habitual correction.
- Is willing and able to follow product usage instructions and maintain the visit schedule.
- Is at least 18 years of age and has full legal capacity to volunteer.
Key exclusion criteria (9 listed)
- Has any active ocular disease.
- Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
- Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)
- Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
- Is using topical ocular prescription or any topical over-the-counter medication.
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 |
|---|---|---|
| Soft contact lens | Device | – |
| Marketed soft lens multipurpose disinfection regimen | Drug | – |
Primary outcome
The primary objective of this study is to compare corneal staining over time in
a group of individuals who wear soft contact lenses on a daily wear basis,
whilst they sequentially use two different contact lens care regimens.
3 secondary outcomes
The secondary objective of this study is to compare subjective ocular symptoms
over time in a group of individuals who wear soft contact lenses on a daily wear
basis, whilst they sequentially use two different contact lens care regimens.
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 16 Dec 2015.
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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.
Craig Woods, PhD principal investigator
University of Waterloo
Desmond Fonn, MOptom principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Soft contact lens and Marketed soft lens multipurpose disinfection regimen in people with Myopia, run by University of Waterloo 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 18 inclusion and 9 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 16 Dec 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective of this study is to compare corneal staining over time in. The study lists 3 primary outcomes in all. 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 16 Dec 2015.