MyopiaNCT01809834

Evaluation of Stenfilcon A Versus Etafilcon A

A study testing Etafilcon A and Stenfilcon A in people with Myopia, run by CooperVision, Inc. 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

Evaluation of two contact lenses Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Myopia
What is being tested?: Etafilcon A and Stenfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteCanada
Study dates: Nov 2012to Nov 2013
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;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
Has astigmatism less than or equal to -1.00D;
Is an adapted soft contact lens wearer;
Demonstrates an acceptable fit with the study lenses;
Has no active anterior segment disease or known ocular disease.

Who cannot join

A person will be excluded from the study if he/she:
Has never worn contact lenses before;
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 (moderate to severe dry eyes) that would affect the wearing of contact lenses;
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;

Show all 11Show fewer

Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
Is aphakic;
Has undergone corneal refractive surgery;
Is participating in any other type of clinical or research study;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Evaluation of two contact lenses

Read the detailed description

One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

Conditions: Myopia
Being tested: Etafilcon A, Stenfilcon A
Medical subject headings: Myopia

What participants receive

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

Etafilcon ADevice
Stenfilcon ADevice

Study groups in NCT01809834
Study group	Role	What they receive
Etafilcon A	Active comparator	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Receives: Device: Stenfilcon A
Stenfilcon A	Experimental	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously Receives: Device: Etafilcon A

What is being measured

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

Participant's Subjective Rating of Comfort (Questionnaire)
Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week
Measured: Insertion, After Lens settling, 12-hours, 1-week
Participant's Subjective Rating of Dryness (Questionnaire)
Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week
Measured: 12-hours, 1-week
Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)
Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing
Measured: Dispense
Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week
Measured: 12-hours, 1-week
Participant's Subjective Rating of Visual Quality (Questionnaire)
Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week
Measured: 12-hours, 1-week
Participant's Subjective Rating of Overall Preference (Questionnaire)
Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week
Measured: 12-hours, 1-week

Secondary outcomes (6)

Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced).
Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week).
Measured: Insertion, 12 hours, 1 week
Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good).
Change over time measured at insertion, 12-hours, 1-week
Measured: Insertion, 12 hours, 1 week
Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination).
(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Measured: Insertion
Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination).
(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Measured: Insertion, 12-hours, 1-week
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week
Measured: Baseline, 12-hours, 1-week
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week
Measured: Baseline, 12-hours, 1-week

Timeline

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

Nov 2012Nov 2013

First posted13 Mar 2013 (estimated)
Study startNov 2012
Primary completionFeb 2013
Study completionNov 2013

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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01809834
Sponsor's protocol ID: CV-12-57
Status last verified: Jul 2020
First submitted: 17 Jan 2013
Last updated: 28 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: 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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Stenfilcon A Versus Etafilcon A
ClinicalTrials.gov ID: NCT01809834
Acronym / sponsor ID: CV-12-57
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Feb 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 13 Mar 2013 (estimated)
Results: Posted 27 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluation of two contact lenses

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Etafilcon A	Active comparator	Device: Stenfilcon AEach participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Stenfilcon A	Experimental	Device: Etafilcon AEach participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Who may qualify

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

Key inclusion criteria (8 listed)

Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
Has astigmatism less than or equal to -1.00D;

Key exclusion criteria (11 listed)

A person will be excluded from the study if he/she:
Has never worn contact lenses before;
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 (moderate to severe dry eyes) that would affect the wearing of contact lenses;

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
Etafilcon A	Device	Stenfilcon A
Stenfilcon A	Device	Etafilcon A

Primary outcome

Participant's Subjective Rating of Comfort (Questionnaire)
Time frame: Insertion, After Lens settling, 12-hours, 1-week
Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week
Participant's Subjective Rating of Dryness (Questionnaire)
Time frame: 12-hours, 1-week
Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week
Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)
Time frame: Dispense
Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing
Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
Time frame: 12-hours, 1-week
Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week
Participant's Subjective Rating of Visual Quality (Questionnaire)
Time frame: 12-hours, 1-week
Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week
Participant's Subjective Rating of Overall Preference (Questionnaire)
Time frame: 12-hours, 1-week
Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week

6 secondary outcomes

Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
Time frame: Insertion, 12 hours, 1 week
Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
Time frame: Insertion, 12 hours, 1 week
Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
Time frame: Insertion
Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
Time frame: Insertion, 12-hours, 1-week
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
Time frame: Baseline, 12-hours, 1-week
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
Time frame: Baseline, 12-hours, 1-week

Results and safety

Results posted to the registry on 27 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	44	44

Primary outcome: Participant's Subjective Rating of Comfort (Questionnaire)

Time frame: Insertion, After Lens settling, 12-hours, 1-week. Mean (Standard Deviation). Unit: units on a scale

Measure	Etafilcon A n = 44	Stenfilcon A n = 44
Insertion	92 (11)	91 (11)
After settling	96 (7)	93 (10)
12-hours	91 (12)	88 (13)
1-week	90 (10)	90 (10)

Population analysed: One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)

Primary outcome: Participant's Subjective Rating of Dryness (Questionnaire)

Time frame: 12-hours, 1-week. Mean (Standard Deviation). Unit: units on a scale

Measure	Etafilcon A n = 44	Stenfilcon A n = 44
12-hours	86 (17)	83 (21)
1-week	83 (20)	82 (21)

Primary outcome: Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)

Time frame: Dispense. Mean (Standard Deviation). Unit: score on a scale

Measure	Etafilcon A n = 44	Stenfilcon A n = 44
Value	80 (19)	86 (14)

Primary outcome: Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)

Time frame: 12-hours, 1-week. Mean (Standard Deviation). Unit: units on a scale

Measure	Etafilcon A n = 44	Stenfilcon A n = 44
12-hours	97 (7)	92 (15)
1-week	94 (12)	94 (9)

Population analysed: One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 44 (0%)	0 of 44 (0%)	Not reported

Limitations and caveats (from the sponsor): One participant temporarily discontinued after 12-hour visit. (Primary outcome 1 and 4,1-week visit, n=43)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

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Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
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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.

Lyndon Jones, PhD., FCO principal investigator

Univeristy of Waterloo, Canada

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Etafilcon A and Stenfilcon A in people with Myopia, run by CooperVision, Inc. 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 8 inclusion and 11 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 28 Jul 2020. 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 27 Jun 2014). 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?

Participant's Subjective Rating of Comfort (Questionnaire) (time frame: Insertion, After Lens settling, 12-hours, 1-week). The study lists 6 primary outcomes in all. 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 NCT01809834.

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 28 Jul 2020; AzTrials last refreshed its copy on 2 Nov 2026.