MyopiaQUINCENCT00934102

Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

A study testing Narafilcon A contact lens, Lotrafilcon A contact lens and Galyfilcon A contact lens in people with Myopia, run by CIBA VISION at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Myopia
What is being tested?: Narafilcon A contact lens, Lotrafilcon A contact lens and Galyfilcon A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteCanada
Study dates: Aug 2009to Sep 2009
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 and has full legal capacity to volunteer
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
Has had an ocular examination in the last two years
Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
Has clear corneas and no active ocular disease
Can be successfully fit with the lenses to be used in the study
Other protocol-defined inclusion/exclusion criteria may apply

Who cannot join

Is pregnant or lactating
Has undergone corneal refractive surgery
Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
Other protocol-defined inclusion/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

Other trials in Canada

About this study

Official title: Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)

The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.

Conditions: Myopia
Being tested: Narafilcon A contact lens, Lotrafilcon A contact lens, Galyfilcon A contact lens
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Narafilcon A contact lensDevice
Investigational, silicone hydrogel, spherical soft contact lens
Lotrafilcon A contact lensDevice
Commercially marketed, silicone hydrogel, spherical soft contact lens
Galyfilcon A contact lensDevice
Commercially marketed, silicone hydrogel, spherical soft contact lens

Study groups in NCT00934102
Study group	Role	What they receive
Lotrafilcon A	Active comparator	Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis. Receives: Device: Lotrafilcon A contact lens
Narafilcon A	Active comparator	Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis. Receives: Device: Narafilcon A contact lens
Galyfilcon A	Active comparator	Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis. Receives: Device: Galyfilcon A contact lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Front Surface Lens Deposits
Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.
Measured: Period 2, Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Sep 2009

First posted8 Jul 2009 (estimated)
Study startAug 2009
Primary completionSep 2009
Study completionSep 2009

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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00934102
Sponsor's protocol ID: P-368-C-103
Acronym: QUINCE
Status last verified: Nov 2010
First submitted: 6 Jul 2009
Last updated: 10 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)
ClinicalTrials.gov ID: NCT00934102
Acronym / sponsor ID: QUINCE / P-368-C-103
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: CIBA VISIONIndustry (pharma, biotech, devices)
Collaborators: University of Waterloo
Study start: Aug 2009
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 8 Jul 2009 (estimated)
Results: Posted 1 Dec 2010

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 assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Lotrafilcon A	Active comparator	Device: Lotrafilcon A contact lensLotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Narafilcon A	Active comparator	Device: Narafilcon A contact lensNarafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Galyfilcon A	Active comparator	Device: Galyfilcon A contact lensGalyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Is at least 17 years of age and has full legal capacity to volunteer
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
Has had an ocular examination in the last two years
Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
Has clear corneas and no active ocular disease

Key exclusion criteria (4 listed)

Is pregnant or lactating
Has undergone corneal refractive surgery
Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
Other protocol-defined inclusion/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
Narafilcon A contact lensInvestigational, silicone hydrogel, spherical soft contact lens	Device	Narafilcon A
Lotrafilcon A contact lensCommercially marketed, silicone hydrogel, spherical soft contact lens	Device	Lotrafilcon A
Galyfilcon A contact lensCommercially marketed, silicone hydrogel, spherical soft contact lens	Device	Galyfilcon A

Primary outcome

Front Surface Lens Deposits
Time frame: Period 2, Day 6
Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.

Results and safety

Results posted to the registry on 1 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Narafilcon A / Lotrafilcon A	16	15
Narafilcon A / Galyfilcon A	15	15
Lotrafilcon A / Galyfilcon A	15	15

Primary outcome: Front Surface Lens Deposits

Time frame: Period 2, Day 6. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Lotrafilcon A n = 15	Narafilcon A n = 15	Galyfilcon A n = 15
Value	0.68 (0.35)	0.78 (0.67)	0.77 (0.61)

Population analysed: Per Protocol. Only the data from participants who completed all study visits were analyzed.

Adverse events

Time frame: Adverse event data were collected for the duration of the trial: 3 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lotrafilcon A	0 of 30 (0%)	0 of 30 (0%)	Not reported
Narafilcon A	0 of 30 (0%)	0 of 30 (0%)	Not reported
Galyfilcon A	0 of 30 (0%)	0 of 30 (0%)	Not reported

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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Recruiting
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Not yet recruiting
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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 Narafilcon A contact lens, Lotrafilcon A contact lens and Galyfilcon A contact lens 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 7 inclusion and 4 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 1 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?

Front Surface Lens Deposits (time frame: Period 2, Day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00934102.

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.