MyopiaPhase 3NCT00349856
Dispensing Overnight Study in Lenses
A Phase 3 study testing Biofinity in people with Myopia, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Biofinity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to Mar 2008
- Phase
- Phase 3
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has had an oculo-visual examination in the last 2 years.
- Is between 18-45 years old and has full legal capacity to volunteer.
- Has read and understood the Information Consent Letter
- Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
- Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step).
- Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye.
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- Is a current soft contact lens wearer (both daily wear and extended wear experience allowed).
- Has refractive astigmatism of <= 1.00 diopters
- Has clear corneas and ocular clinical findings considered to be "normal".
Who cannot join
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities.
- Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant.
- Has never worn contact lenses before.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L3G1
About this study
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping.
Read the detailed description
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping. Physiological changes will be monitored and subjective ratings collected.
- Conditions
- Myopia
- Being tested
- Biofinity
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofinityDevice
Also called Purevision
Soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: Biofinity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this trial is to assess safety of the investigational
Measured: study visits, three monthly
Secondary outcomes (1)
The secondary objective of this trial is to assess the subjective responses to comfort with both the investigational and marketed lenses.
Measured: study visits, three monthly
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 startJan 2005
- Primary completionMar 2008
- Study completionMar 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Cooper Companies
- Investigators
- Desmond Fonn, MOptom, Principal investigator, Centre for Contact Lens Research, University of Waterloo.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349856
- Sponsor's protocol ID
- P/209/04/O
- Status last verified
- Feb 2009
- First submitted
- 5 Jul 2006
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispensing Overnight Study in Lenses
- ClinicalTrials.gov ID
- NCT00349856
- Acronym / sponsor ID
- P/209/04/O
- Conditions
- Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Cooper Companies
- Study start
- Jan 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- 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 purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping.
Detailed description
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping. Physiological changes will be monitored and subjective ratings collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Biofinity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Has had an oculo-visual examination in the last 2 years.
- Is between 18-45 years old and has full legal capacity to volunteer.
- Has read and understood the Information Consent Letter
- Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
- Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step).
Key exclusion criteria (10 listed)
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
- Has any clinically significant lid or conjunctival abnormalities, 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 |
|---|---|---|
| BiofinityAlso: PurevisionSoft contact lens | Device | 1 |
Primary outcome
The primary objective of this trial is to assess safety of the investigational
Time frame: study visits, three monthly
1 secondary outcome
The secondary objective of this trial is to assess the subjective responses to comfort with both the investigational and marketed lenses.
Time frame: study visits, three monthly
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 18 Feb 2009.
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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.
Desmond Fonn, MOptom principal investigator
Centre for Contact Lens Research, 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 3 study testing Biofinity 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 9 inclusion and 10 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 18 Feb 2009. 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?
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 trial is to assess safety of the investigational (time frame: study visits, three monthly). 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 18 Feb 2009.