AmetropiaPhase 3NCT00371787
Evaluation of the Performance of Non-molded Soft Contact Lenses
A Phase 3 study testing Soft contact lens in people with Ametropia, run by University of Waterloo at 1 site in Canada.
Trial summary
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ametropia
- What is being tested?
- Soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2006to Dec 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood \& signed consent form.
Who cannot join
- Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
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
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
Read the detailed description
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.
- Conditions
- Ametropia
- Being tested
- Soft contact lens
- 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
Also called Custom O2Optix
Soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| soft contact lens | Experimental | Not described Receives: Device: Soft contact lens |
| non-lens wear | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Measured: baseline
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Measured: 9 month
Neovascularisation
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Measured: baseline
Neovascularization
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- CIBA VISION
- Investigators
- Desmond Fonn, Principal investigator, Centre for Contact Lens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371787
- Sponsor's protocol ID
- P/240/06/CV
- Status last verified
- Jan 2011
- First submitted
- 1 Sep 2006
- Last updated
- 10 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of Non-molded Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT00371787
- Acronym / sponsor ID
- P/240/06/CV
- Conditions
- Ametropia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- CIBA VISION
- Study start
- Aug 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 13 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
Detailed description
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| soft contact lens | Experimental | Device: Soft contact lens |
| non-lens wear | No intervention | –control group |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood \& signed consent form.
Key exclusion criteria (1 listed)
- Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
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 lensAlso: Custom O2OptixSoft contact lens | Device | soft contact lens |
Primary outcome
Visual Acuity
Time frame: baseline
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Visual Acuity
Time frame: 9 month
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Neovascularisation
Time frame: baseline
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Neovascularization
Time frame: 9 month
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
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Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
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A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
Refractive Ametropia
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.
Desmond Fonn principal investigator
Centre for Contact Lens Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Soft contact lens 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 1 inclusion and 1 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 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Acuity (time frame: baseline). The study lists 4 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 10 Jan 2011.