MyopiaCIANNCT01010555
In-vivo Wettability Grading and Assessment Study
A study testing lotrafilcon B, balafilcon A and senofilcon A in people with Myopia, run by CIBA VISION at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- lotrafilcon B, balafilcon A and senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Apr 2010
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- is at least 17 years of age
- has read and signed an information consent letter
- is a current daily wear contact lens wearer
- has acceptable fit with the study lenses
- has had an ocular exam in the last two years
- other protocol-defined inclusion criteria may apply
Who cannot join
- has any ocular disease
- has undergone corneal refractive surgery or is aphakic
- has any systemic disease affecting ocular health
- is pregnant or lactating
- 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, Ontario, N2L 3G1
About this study
The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.
- Conditions
- Myopia
- Being tested
- lotrafilcon B, balafilcon A, senofilcon A, enfilcon A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lotrafilcon BDevice
Also called Air Optix
Commercially marketed, silicone hydrogel, spherical contact lens
balafilcon ADevice
Also called PureVision
Commercially marketed, silicone hydrogel, spherical contact lens
senofilcon ADevice
Also called Acuvue OASYS
Commercially marketed, silicone hydrogel, spherical contact lens
enfilcon ADevice
Also called Avaira
Commercially marketed, silicone hydrogel, spherical contact lens
| Study group | Role | What they receive |
|---|---|---|
| lotrafilcon B | Active comparator | Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. Receives: Device: lotrafilcon B |
| balafilcon A | Active comparator | Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. Receives: Device: balafilcon A |
| senofilcon A | Active comparator | Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. Receives: Device: senofilcon A |
| enfilcon A | Active comparator | Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. Receives: Device: enfilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
On-eye Wettability
On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.
Measured: 4 weeks of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionApr 2010
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010555
- Sponsor's protocol ID
- P-368-C-104
- Acronym
- CIAN
- Status last verified
- Jan 2012
- First submitted
- 9 Nov 2009
- Last updated
- 10 Jul 2012
- 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 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vivo Wettability Grading and Assessment Study
- ClinicalTrials.gov ID
- NCT01010555
- Acronym / sponsor ID
- CIAN / P-368-C-104
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Posted 30 May 2011
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 investigate the front surface wettability of soft contact lenses while on eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lotrafilcon B | Active comparator | Device: lotrafilcon BLotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. |
| balafilcon A | Active comparator | Device: balafilcon ABalafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. |
| senofilcon A | Active comparator | Device: senofilcon ASenofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. |
| enfilcon A | Active comparator | Device: enfilcon AEnfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- is at least 17 years of age
- has read and signed an information consent letter
- is a current daily wear contact lens wearer
- has acceptable fit with the study lenses
- has had an ocular exam in the last two years
Key exclusion criteria (5 listed)
- has any ocular disease
- has undergone corneal refractive surgery or is aphakic
- has any systemic disease affecting ocular health
- is pregnant or lactating
- other protocol-defined exclusion criteria may apply
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 |
|---|---|---|
| lotrafilcon BAlso: Air OptixCommercially marketed, silicone hydrogel, spherical contact lens | Device | lotrafilcon B |
| balafilcon AAlso: PureVisionCommercially marketed, silicone hydrogel, spherical contact lens | Device | balafilcon A |
| senofilcon AAlso: Acuvue OASYSCommercially marketed, silicone hydrogel, spherical contact lens | Device | senofilcon A |
| enfilcon AAlso: AvairaCommercially marketed, silicone hydrogel, spherical contact lens | Device | enfilcon A |
Primary outcome
On-eye Wettability
Time frame: 4 weeks of wear
On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lotrafilcon B, balafilcon A and senofilcon A in people with Myopia, run by CIBA VISION 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 5 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 Jul 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?
Yes. Results are posted in the registry (first posted 30 May 2011). 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?
On-eye Wettability (time frame: 4 weeks of wear). 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 Jul 2012.