MyopiaNCT02341859

Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

A study testing stenfilcon A, delefilcon A and narafilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United States.

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

Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1® Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Myopia
What is being tested?: stenfilcon A, delefilcon A and narafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Jul 2015
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 18 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted soft spherical contact lens wearer
Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye

Show all 12Show fewer

Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter
Patient contact lens refraction should fit within the available parameters of the study lenses
Is willing to comply with the wear schedule
Is willing to comply with the visit schedule

Who cannot join

Is not a habitual wearer of soft spherical contact lenses
Has a contact lens prescription outside the range of the available parameters of the study lenses
Has a contact lens prescription outside the range of the inclusion power range
Has a spectacle cylinder ≥1.00D of cylinder in either eye
Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye

Show all 22Show fewer

Presence of clinically significant (grade > 2) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
Slit lamp findings that would contraindicate contact lens wear such as:
Moderate to severe dry eye
Pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Giant papillary conjunctivitis (GCP) worse than grade 1
Anterior uveitis or iritis (past or present)
Seborrheic eczema, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea
Has Presbyopia or has dependence on spectacles for near work over the contact lenses
Has undergone corneal refractive surgery
Is participating in any other type of eye related clinical or research study

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research Center, University of California, Berkeley
Berkeley, California, 94704

Other trials in United States

About this study

Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

Read the detailed description

The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4 base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0 base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.

Conditions: Myopia
Being tested: stenfilcon A, delefilcon A, narafilcon A
Medical subject headings: Myopia

What participants receive

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

stenfilcon ADevice
Also called MyDay
contact lens
delefilcon ADevice
Also called 1-DAY ACUVUE
contact lens
narafilcon ADevice
Also called DAILIES TOTAL1
contact lens

Study groups in NCT02341859
Study group	Role	What they receive
stenfilcon A and delefilcon A	Active comparator	Participants randomized wear the stenfilcon A and the delefilcon A contralaterally. Receives: Device: stenfilcon A; Device: delefilcon A
stenfilcon A and narafilcon A	Active comparator	Participants randomized wear the stenfilcon A and the narafilcon A contralaterally Receives: Device: stenfilcon A; Device: narafilcon A

What is being measured

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

Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Measured: Baseline
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Measured: 6 hours
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Measured: Baseline
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Measured: 6 hours
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe)
N - nasal, T - temporal, S - superior, I - interior
Measured: Baseline
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Measured: 6 hours
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Measured: Baseline
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Measured: 6 hours
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Measured: Baseline
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Measured: 6 hours
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Measured: Baseline
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Measured: 6 hours
Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)
Measured: 6 hours
Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)
Measured: 6 hours
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.
Measured: Baseline
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.
Measured: 6 hours
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Measured: Baseline
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Measured: 6 hours
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)
Measured: Baseline
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)
Measured: 6 hours
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)
Measured: Baseline
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)
Measured: 6 hours
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)
Measured: Baseline
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)
Measured: 6 hours
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Measured: Baseline
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Measured: 6 hours

Secondary outcomes (11)

Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Measured: Baseline
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Measured: 6 hours
Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Measured: Baseline
Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Measured: 6 hours
Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Measured: 6 hours
Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness).
Measured: Baseline, 3 hours, 6 hours
Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling).
Measured: Baseline, 3 hours, 6 hours
Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all).
Measured: Baseline and 6 hours
Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image).
Measured: Baseline, 3 hours, 6 hours
Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied).
Measured: 6 hours
Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred)
Measured: 6 hours

Timeline

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

Jan 2015Jul 2015

First posted19 Jan 2015 (estimated)
Study startJan 2015
Primary completionJun 2015
Study completionJul 2015

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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02341859
Sponsor's protocol ID: JP-MKTG-201501
Status last verified: Jan 2017
First submitted: 14 Jan 2015
Last updated: 10 Mar 2017
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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
ClinicalTrials.gov ID: NCT02341859
Acronym / sponsor ID: JP-MKTG-201501
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 19 Jan 2015 (estimated)
Results: Posted 26 May 2016

Clinical summary

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

Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

Detailed description

Study design

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

Arm	Type	Receives
stenfilcon A and delefilcon A	Active comparator	Device: stenfilcon A, Device: delefilcon AParticipants randomized wear the stenfilcon A and the delefilcon A contralaterally.
stenfilcon A and narafilcon A	Active comparator	Device: stenfilcon A, Device: narafilcon AParticipants randomized wear the stenfilcon A and the narafilcon A contralaterally

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted soft spherical contact lens wearer
Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography

Key exclusion criteria (22 listed)

Is not a habitual wearer of soft spherical contact lenses
Has a contact lens prescription outside the range of the available parameters of the study lenses
Has a contact lens prescription outside the range of the inclusion power range
Has a spectacle cylinder ≥1.00D of cylinder in either eye
Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)

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
stenfilcon AAlso: MyDaycontact lens	Device	stenfilcon A and delefilcon A, stenfilcon A and narafilcon A
delefilcon AAlso: 1-DAY ACUVUEcontact lens	Device	stenfilcon A and delefilcon A
narafilcon AAlso: DAILIES TOTAL1contact lens	Device	stenfilcon A and narafilcon A

Primary outcome

Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)
Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).

11 secondary outcomes

Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline
Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline, 3 hours, 6 hours
Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline, 3 hours, 6 hours
Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline and 6 hours
Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: Baseline, 3 hours, 6 hours
Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours
Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
Time frame: 6 hours

Results and safety

Results posted to the registry on 26 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stenfilcon A/Delefilcon A, Then Stenfilcon A/Narafilcon A	10	10
Stenfilcon A/Narafilcon A, Then Stenfilcon A/Delefilcon A	9	9

Primary outcome: Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A (Delefilcon A Group) n = 19	Delefilcon A n = 19	Stenfilcon A (Narafilcon A Group) n = 19	Narafilcon A n = 19
N	0.42 (0.48)	0.53 (0.51)	0.68 (0.53)	0.47 (0.49)
T	0.39 (0.43)	0.34 (0.50)	0.34 (0.37)	0.45 (0.44)
S	0.13 (0.23)	0.16 (0.24)	0.21 (0.30)	0.21 (0.30)
I	0.26 (0.26)	0.18 (0.34)	0.24 (0.35)	0.34 (0.37)

Primary outcome: Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

Time frame: 6 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A (Delefilcon A Group) n = 19	Delefilcon A n = 19	Stenfilcon A (Narafilcon A Group) n = 19	Narafilcon A n = 19
N	0.97 (0.49)	0.79 (0.54)	1.00 (0.75)	1.29 (0.87)
T	1.11 (0.74)	0.47 (0.46)	1.39 (0.89)	0.97 (0.68)
S	0.26 (0.45)	0.24 (0.31)	0.45 (0.60)	0.61 (1.04)
I	0.53 (0.56)	0.63 (0.60)	0.87 (0.60)	1.24 (1.03)

Primary outcome: Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A (Delefilcon A Group) n = 19	Delefilcon A n = 19	Stenfilcon A (Narafilcon A Group) n = 19	Narafilcon A n = 19
N	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.08 (0.34)
T	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)
S	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)
I	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.08 (0.34)

Primary outcome: Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A

Time frame: 6 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A (Delefilcon A Group) n = 19	Delefilcon A n = 19	Stenfilcon A (Narafilcon A Group) n = 19	Narafilcon A n = 19
N	0.05 (0.16)	0.16 (0.34)	0.26 (0.45)	0.08 (0.34)
T	0.18 (0.38)	0.05 (0.16)	0.53 (0.70)	0.11 (0.36)
S	0.11 (0.32)	0.00 (0.00)	0.21 (0.45)	0.21 (0.45)
I	0.16 (0.34)	0.11 (0.27)	0.21 (0.35)	0.13 (0.33)

11 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
Stenfilcon A	0 of 19 (0%)	0 of 19 (0%)	Not reported
Delefilcon A	0 of 19 (0%)	0 of 19 (0%)	Not reported
Narafilcon A	0 of 19 (0%)	0 of 19 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
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.

Meng C Lin, OD PhD principal investigator

CRC-UC Berkeley

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

Questions about this trial

What is this clinical trial studying?

A study testing stenfilcon A, delefilcon A and narafilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United States.

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 12 inclusion and 22 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 Mar 2017. 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 United States. 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 26 May 2016). 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?

Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A (time frame: Baseline). The study lists 26 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 NCT02341859.

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 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.