Visual AcuityNCT02568254

Evaluation of Three Daily Disposable Contact Lenses

A study testing Lens 1 (etafilcon A), Lens 2 (nelfilcon A) and Lens 3 (nesofilcon A) in people with Visual Acuity, run by Johnson & Johnson Vision Care, 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

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: Lens 1 (etafilcon A), Lens 2 (nelfilcon A) and Lens 3 (nesofilcon A)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteCanada
Study dates: 3 Sep 2015to 18 Jan 2016
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
Healthy volunteers accepted
Adult

Who may be able to join

The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form;
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol;
The subject must be willing and able to follow instructions and maintain the appointment schedule;
The subject must be between the age of 18 and 40 years (inclusive);
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -6.00 D in each eye (inclusive);
The subject's refractive cylinder must not exceed -1.25 Diopters of Cylinder (DC) in each eye after vertexing to the corneal plane;

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The subject must have best corrected visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye;
The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment;
The subject must own a wearable pair of spectacles and wear them the day of the initial visit;
The subject must be an existing wearer of spherical, soft contact lenses in both eyes;
The subject must have normal eyes (i.e., no ocular medications or infections of any type);
The subject must be willing to wear the study lenses for a minimum eight hours per day.

Who cannot join

Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion);
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion);
Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued);
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease;
Any active ocular infection;
Is using any topical medications (excluding artificial tears (ATS)) up to two weeks prior to the screening visit;

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Any participants whose habitual contact lenses are used as an extended wear regimen;
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry;
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.);
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear; or clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear;
Any known hypersensitivity or allergic reaction to the study products;
Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment;
Employee or family member of the Centre for Contact Lens Research (e.g., Investigator, Coordinator, Technician).

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Contact Lens Research
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

This is a single-site, 8-visit, double-masked, cross-over study involving three marketed products as study lenses. Participants will be randomly assigned each lens type, which will be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum washout period of 3 days before entering the study and undergo a minimum 7 day washout period between dispensing each lens type.

Conditions: Visual Acuity
Being tested: Lens 1 (etafilcon A), Lens 2 (nelfilcon A), Lens 3 (nesofilcon A)

What participants receive

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

Lens 1 (etafilcon A)Device
Also called 1-Day Acuvue® Moist®
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Lens 2 (nelfilcon A)Device
Also called Dailies® AquaComfort Plus®
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Lens 3 (nesofilcon A)Device
Also called Biotrue ONEday
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).

Study groups in NCT02568254
Study group	Role	What they receive
Lens 1/ Lens 2/ Lens 3	Active comparator	Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (nesofilcon A) third. Receives: Device: Lens 1 (etafilcon A); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)
Lens 1 / Lens 3 / Lens 2	Active comparator	Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 2 (nelfilcon A) third. Receives: Device: Lens 1 (etafilcon A); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)
Lens 2/ Lens 3/ Lens 1	Active comparator	Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 1 (etafilcon A) third . Receives: Device: Lens 1 (etafilcon A); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)
Lens 2 / Lens 1/ Lens 3	Active comparator	Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nesofilcon A) third. Each lens type will be worn for approximately 2 weeks (12 +/- 2 days). Receives: Device: Lens 1 (etafilcon A); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)
Lens 3 / Lens 1 / Lens 2	Active comparator	Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nelfilcon A) third. Receives: Device: Lens 1 (etafilcon A); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)
Lens 3 / Lens 2 / Lens 1	Active comparator	Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (etafilcon A) third. Receives: Device: Lens 1 (etafilcon A); Device: Lens 2 (nelfilcon A); Device: Lens 3 (nesofilcon A)

What is being measured

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

Overall Comfort
Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Measured: 2- Week Follow-up

Timeline

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

3 Sep 201518 Jan 2016

First posted5 Oct 2015 (estimated)
Study start3 Sep 2015
Primary completion18 Jan 2016
Study completion18 Jan 2016

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 Visual AcuityStudies 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02568254
Sponsor's protocol ID: CR-5735
Status last verified: Jul 2017
First submitted: 22 Sep 2015
Last updated: 17 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

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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Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
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Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration

All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Three Daily Disposable Contact Lenses
ClinicalTrials.gov ID: NCT02568254
Acronym / sponsor ID: CR-5735
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 3 Sep 2015 (actual)
Primary completion: 18 Jan 2016 (actual)
Study completion: 18 Jan 2016 (actual)
First posted: 5 Oct 2015 (estimated)
Results: Posted 17 Jul 2017

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Lens 1/ Lens 2/ Lens 3	Active comparator	Device: Lens 1 (etafilcon A), Device: Lens 2 (nelfilcon A), Device: Lens 3 (nesofilcon A)Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (nesofilcon A) third.
Lens 1 / Lens 3 / Lens 2	Active comparator	Device: Lens 1 (etafilcon A), Device: Lens 2 (nelfilcon A), Device: Lens 3 (nesofilcon A)Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 2 (nelfilcon A) third.
Lens 2/ Lens 3/ Lens 1	Active comparator	Device: Lens 1 (etafilcon A), Device: Lens 2 (nelfilcon A), Device: Lens 3 (nesofilcon A)Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 1 (etafilcon A) third .
Lens 2 / Lens 1/ Lens 3	Active comparator	Device: Lens 1 (etafilcon A), Device: Lens 2 (nelfilcon A), Device: Lens 3 (nesofilcon A)Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nesofilcon A) third. Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Lens 3 / Lens 1 / Lens 2	Active comparator	Device: Lens 1 (etafilcon A), Device: Lens 2 (nelfilcon A), Device: Lens 3 (nesofilcon A)Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nelfilcon A) third.
Lens 3 / Lens 2 / Lens 1	Active comparator	Device: Lens 1 (etafilcon A), Device: Lens 2 (nelfilcon A), Device: Lens 3 (nesofilcon A)Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (etafilcon A) third.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form;
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol;
The subject must be willing and able to follow instructions and maintain the appointment schedule;
The subject must be between the age of 18 and 40 years (inclusive);
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -6.00 D in each eye (inclusive);

Key exclusion criteria (13 listed)

Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion);
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion);
Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued);
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease;
Any active ocular infection;

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
Lens 1 (etafilcon A)Also: 1-Day Acuvue® Moist®Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).	Device	Lens 1 / Lens 3 / Lens 2, Lens 1/ Lens 2/ Lens 3, Lens 2 / Lens 1/ Lens 3, Lens 2/ Lens 3/ Lens 1, Lens 3 / Lens 1 / Lens 2, Lens 3 / Lens 2 / Lens 1
Lens 2 (nelfilcon A)Also: Dailies® AquaComfort Plus®Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).	Device	Lens 1 / Lens 3 / Lens 2, Lens 1/ Lens 2/ Lens 3, Lens 2 / Lens 1/ Lens 3, Lens 2/ Lens 3/ Lens 1, Lens 3 / Lens 1 / Lens 2, Lens 3 / Lens 2 / Lens 1
Lens 3 (nesofilcon A)Also: Biotrue ONEdayEach lens type will be worn for approximately 2 weeks (12 +/- 2 days).	Device	Lens 1 / Lens 3 / Lens 2, Lens 1/ Lens 2/ Lens 3, Lens 2 / Lens 1/ Lens 3, Lens 2/ Lens 3/ Lens 1, Lens 3 / Lens 1 / Lens 2, Lens 3 / Lens 2 / Lens 1

Primary outcome

Overall Comfort
Time frame: 2- Week Follow-up
Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Results and safety

Results posted to the registry on 17 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etafilcon A/ Nelfilcon A/ Nesofilcon A	13	13
Etafilcon A/ Nesofilcon A/ Nelfilcon A	12	12
Nelfilcon A/ Nesofilcon A/ Etafilcon A	13	13
Nelfilcon A/ Etafilcon A/ Nesofilcon A	12	12
Nesolfilcon A/ Etafilcon A/ Nelfilcon A	12	12
Nesofilcon A/ Nelfilcon A/Etafilcon A	12	12

Primary outcome: Overall Comfort

Time frame: 2- Week Follow-up. Mean (Standard Deviation). Unit: Units on a scale

Measure	Etafilcon A n = 72	Nelfilcon A n = 72	Nesofilcon A n = 72
Value	58.74 (25.350)	48.14 (25.166)	57.32 (25.84)

Population analysed: Subjects that completed all study visits without a major protocol deviation.

Adverse events

Time frame: Throughout the entire duration of the study. Approximately 6 weeks per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A	0 of 74 (0%)	0 of 74 (0%)	Not reported
Nelfilcon A	0 of 74 (0%)	0 of 74 (0%)	Not reported
Nesofilcon A	0 of 74 (0%)	0 of 74 (0%)	Not reported

Limitations and caveats (from the sponsor): Caution of interpretation of results: A significant first-order carryover effect was noted in the study analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Visual Acuity

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
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Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration

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 Lens 1 (etafilcon A), Lens 2 (nelfilcon A) and Lens 3 (nesofilcon A) in people with Visual Acuity, run by Johnson & Johnson Vision Care, 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 12 inclusion and 13 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 17 Jul 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 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 17 Jul 2017). 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?

Overall Comfort (time frame: 2- Week Follow-up). 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 NCT02568254.

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 17 Jul 2017.