AmetropiaPhase 4NCT00349063
Contact Lens Wettability
A Phase 4 study testing soft contact lens and Soft contact lens multipurpose disinfection regimen in people with Ametropia, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this study is to compare the wettability of contact lenses disinfected with three marketed contact lens care solutions. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ametropia
- What is being tested?
- soft contact lens and Soft contact lens multipurpose disinfection regimen
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Jul 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
- Child, Adult, Older adult
Who may be able to join
- Has had an oculo-visual examination in the last two years.
- Is at least 18 years old and has full legal capacity to volunteer or is at least 16 years old, has a parent or guardian's permission to participate in the study and has read the Information and Consent Letter for adolescents.
- 4. Has read and understood the Information Consent Letter (Appendix II). 5. Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
- 6. Has a refractive error that is correctable with the prescription of the available study lenses.
- 7. Has a refractive error that is correctable to at least 20/25 distance visual acuity with contact lenses in each eye.
- 8. Has acceptable fit with the study lenses. 9. Has clear corneas, and ocular clinical findings are considered "normal".
Who cannot join
- Has any systemic disease that may affect ocular health.
- Is using any systemic or topical medications that may affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that may affect the wearing of contact lenses.
- Has any clinically significant lid or conjunctival abnormalities, meibomian gland dysfunction, neovascularization, corneal scars or corneal opacities.
- Has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant.
- Has pinguecula and/or pterygium that, in the investigator's judgement, makes contact lens wear inadvisable.
Show all 12Show fewer
- Has refractive astigmatism of more than 0.75 D.
- Has corneal distortion resulting from rigid lens wear.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of clinical or research study.
- Is pregnant or lactating.
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: The Impact of Short Term Wearing Time on In Vivo and Ex Vivo Wettability
The purpose of this study is to compare the wettability of contact lenses disinfected with three marketed contact lens care solutions.
- Conditions
- Ametropia
- Being tested
- soft contact lens, Soft contact lens multipurpose disinfection regimen
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft contact lensDevice
Soft contact lens multipurpose disinfection regimenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the impact of wearing time and contact lens care solutions on in
vivo and ex vivo wettability of currently marketed contact lenses
Secondary outcomes (3)
To determine if there is a correlation between in vivo wettability, ex vivo
wettability and in-eye comfort. To determine if comfort and wettability vary
between symptomatic and asymptomatic lens wearers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmetropiaStudies 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
- 55 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
- NCT00349063
- Sponsor's protocol ID
- P/217/05/L
- Status last verified
- Jul 2006
- First submitted
- 4 Jul 2006
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Short Term Wearing Time on In Vivo and Ex Vivo Wettability
- ClinicalTrials.gov ID
- NCT00349063
- Acronym / sponsor ID
- P/217/05/L
- Conditions
- Ametropia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Jul 2005
- First posted
- 6 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 purpose of this study is to compare the wettability of contact lenses disinfected with three marketed contact lens care solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Has had an oculo-visual examination in the last two years.
- Is at least 18 years old and has full legal capacity to volunteer or is at least 16 years old, has a parent or guardian's permission to participate in the study and has read the Information and Consent Letter for adolescents.
- 4. Has read and understood the Information Consent Letter (Appendix II). 5. Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
- 6. Has a refractive error that is correctable with the prescription of the available study lenses.
- 7. Has a refractive error that is correctable to at least 20/25 distance visual acuity with contact lenses in each eye.
Key exclusion criteria (12 listed)
- Has any systemic disease that may affect ocular health.
- Is using any systemic or topical medications that may affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that may affect the wearing of contact lenses.
- Has any clinically significant lid or conjunctival abnormalities, meibomian gland dysfunction, neovascularization, corneal scars or corneal opacities.
- Has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant.
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 | – |
| Soft contact lens multipurpose disinfection regimen | Drug | – |
Primary outcome
To investigate the impact of wearing time and contact lens care solutions on in
vivo and ex vivo wettability of currently marketed contact lenses
3 secondary outcomes
To determine if there is a correlation between in vivo wettability, ex vivo
wettability and in-eye comfort. To determine if comfort and wettability vary
between symptomatic and asymptomatic lens wearers.
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 19 Jul 2006.
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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 Soft contact lens multipurpose disinfection regimen in people with Ametropia, 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 6 inclusion and 12 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 19 Jul 2006. 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?
To investigate the impact of wearing time and contact lens care solutions on in. The study lists 2 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 19 Jul 2006; AzTrials last refreshed its copy on 27 Oct 2026.