Visual AcuityNCT02365298

Clinical and Laboratory Study of Lysozyme Deposition on Daily Disposable Contact Lenses

A study testing etafilcon A and nelfilcon 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

In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel materials and that this protein remains largely active and promotes reduced cytokine response in an in vitro culture of human corneal epithelial cells. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: etafilcon A and nelfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteCanada
Study dates: 1 Jan 2015to 1 Jun 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
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 the clinical protocol.
The subject must be willing to follow instructions and maintain the appointment schedule.
The subject must be between 18 and 40 years of age (inclusive).
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -6.00D in each eye (inclusive).
The subject's refractive cylinder must not exceed -1.25DC in each eye after vertexing to the corneal plane.

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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 to 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 eye (i.e., no ocular medications or infections of any type).
The subject must be able to wear the study lenses for a minimum seven 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 medication including 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.
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; clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
Any know hypersensitivity or allergic reaction to study products.
Participation in any contact lens or lens care product clinical trial within seven days prior to study enrollment.
Employee or family member of the Center for Contact Lens Research (e.g., Investigator, Coordinator, Technician).

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Conditions: Visual Acuity
Being tested: etafilcon A, nelfilcon A

What participants receive

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

etafilcon ADevice
Also called Marketed Investigational Soft Contact Lens
etafilcon A soft contact lens
nelfilcon ADevice
Also called Marketed Investigational Soft Contact Lens
nelfilcon A

Study groups in NCT02365298
Study group	Role	What they receive
etafilcon A	Experimental	Worn in a daily disposable modality Receives: Device: etafilcon A; Device: nelfilcon A
nelfilcon A	Active comparator	Worn in a daily disposable modality Receives: Device: etafilcon A; Device: nelfilcon A

What is being measured

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

Total Protein and Total Lysosome Deposits
Measurement will be taken after the subject has worn the lenses for a full seven hours
Measured: 2 wks after baseline
Total Protein and Total Lysosome Deposits
Measurement will be taken after the subject has worn the lenses for a full seven hours
Measured: 6 wks after baseline
Total Protein and Lysosome Deposits
Measurement will be taken after the subject has worn the lenses for a full seven hours
Measured: 12 wks after baseline
Quantity of Cytokines and Albumin in Tear Fluid
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.
Measured: 2 wks after baseline
Quantity of Cytokines and Albumin in Tear Fluid
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Measured: 6 wks after baseline
Quantity of Cytokines and Albumin in Tear Fluid
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Measured: 12 wks after baseline

Timeline

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

1 Jan 20151 Jun 2015

First posted18 Feb 2015 (estimated)
Study start1 Jan 2015
Primary completion1 Jun 2015
Study completion1 Jun 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 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02365298
Sponsor's protocol ID: CR-5695
Status last verified: Apr 2018
First submitted: 22 Jan 2015
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Laboratory Study of Lysozyme Deposition on Daily Disposable Contact Lenses
ClinicalTrials.gov ID: NCT02365298
Acronym / sponsor ID: CR-5695
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Jan 2015 (actual)
Primary completion: 1 Jun 2015 (actual)
Study completion: 1 Jun 2015 (actual)
First posted: 18 Feb 2015 (estimated)
Results: Posted 13 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
etafilcon A	Experimental	Device: etafilcon A, Device: nelfilcon AWorn in a daily disposable modality
nelfilcon A	Active comparator	Device: etafilcon A, Device: nelfilcon AWorn in a daily disposable modality

Who may qualify

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

Key inclusion criteria (11 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 the clinical protocol.
The subject must be willing to follow instructions and maintain the appointment schedule.
The subject must be between 18 and 40 years of age (inclusive).
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -6.00D in each eye (inclusive).

Key exclusion criteria (12 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
etafilcon AAlso: Marketed Investigational Soft Contact Lensetafilcon A soft contact lens	Device	etafilcon A, nelfilcon A
nelfilcon AAlso: Marketed Investigational Soft Contact Lensnelfilcon A	Device	etafilcon A, nelfilcon A

Primary outcome

Total Protein and Total Lysosome Deposits
Time frame: 2 wks after baseline
Measurement will be taken after the subject has worn the lenses for a full seven hours
Total Protein and Total Lysosome Deposits
Time frame: 6 wks after baseline
Measurement will be taken after the subject has worn the lenses for a full seven hours
Total Protein and Lysosome Deposits
Time frame: 12 wks after baseline
Measurement will be taken after the subject has worn the lenses for a full seven hours
Quantity of Cytokines and Albumin in Tear Fluid
Time frame: 2 wks after baseline
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.
Quantity of Cytokines and Albumin in Tear Fluid
Time frame: 6 wks after baseline
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Quantity of Cytokines and Albumin in Tear Fluid
Time frame: 12 wks after baseline
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.

Results and safety

Results posted to the registry on 13 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	14	14
Nelfilcon A / Etafilcon A	14	14

Primary outcome: Total Protein and Total Lysosome Deposits

Time frame: 2 wks after baseline. Mean (Standard Deviation). Unit: (ug/lens)

Measure	Etafilcon A n = 24	Nelfilcon A n = 24
Total Lysozyme	294.58 (113.855)	1.68 (0.975)
Active Lysozyme	244.00 (87.325)	0.93 (0.650)
Total Proteins	482.06 (139.196)	6.46 (3.953)

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

Primary outcome: Total Protein and Total Lysosome Deposits

Time frame: 6 wks after baseline. Mean (Standard Deviation). Unit: (ug/lens)

Measure	Etafilcon A n = 12	Nelfilcon A n = 11
Total Lysozyme	349.00 (58.845)	2.26 (1.460)
Active Lysozyme	263.92 (38.562)	1.13 (0.538)
Total Proteins	473.58 (131.432)	7.46 (4.151)

Population analysed: Subjects that completed all study visits without a major protocol deviation. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.

Primary outcome: Total Protein and Lysosome Deposits

Time frame: 12 wks after baseline. Mean (Standard Deviation). Unit: (ug/lens)

Measure	Etafilcon A n = 12	Nelfilcon A n = 12
Total Lysozyme	289.17 (78.838)	1.58 (0.851)
Active Lysozymes	242.75 (57.974)	1.01 (0.567)
Total Proteins	394.42 (122.302)	5.87 (3.181)

Population analysed: All subjects that completed all study visits without a major protocol deviation.During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.

Primary outcome: Quantity of Cytokines and Albumin in Tear Fluid

Time frame: 2 wks after baseline. Mean (Standard Deviation). Unit: (pg/ml)

Measure	Etafilcon A n = 23	Nelfilcon A n = 24
TFN-a	1.20 (0.528)	1.17 (1.095)
IL-1B	1.70 (1.810)	2.32 (3.023)
IL-2	1.19 (0.841)	1.49 (1.770)
IL-6	12.32 (11.756)	15.03 (18.835)
IL-8	466.32 (291.109)	472.91 (273.444)
IL-10	2.02 (1.879)	1.64 (1.389)
IL-12	2.72 (5.218)	2.25 (2.685)
IL-13	29.62 (19.510)	27.23 (23.651)

Population analysed: Subjects that completed all study visits without a major protocol deviation. All 24 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.

Adverse events

Time frame: Approximately 81-87 days per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A	0 of 28 (0%)	0 of 28 (0%)	Not reported
Nelfilcon A	0 of 28 (0%)	2 of 28 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing etafilcon A and nelfilcon 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 11 inclusion and 12 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 19 Jun 2018. 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 13 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?

Total Protein and Total Lysosome Deposits (time frame: 2 wks after baseline). 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 NCT02365298.

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 19 Jun 2018.