PresbyopiaNCT02310126

Handling Comparison Between Two Contact Lens Types

A study testing etafilcon A (multi-focal) and etafilcon A (sphere) in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 8 sites 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

Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period. Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Presbyopia
What is being tested?: etafilcon A (multi-focal) and etafilcon A (sphere)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 195 participants
Where: 8 sitesUnited States
Study dates: 1 Nov 2014to 1 Dec 2014
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 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older 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 between 40 and 70 years of age.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.
The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.

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The subject best corrected visual acuity of 20/20 -3 or better in each eye.
Subject must own a wearable pair of spectacles.
The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)
The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Who cannot join

Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
Any ocular abnormality that may interfere with contact lens wear.
Use of any ocular medication, with the exception of rewetting drops.
Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

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Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
Any ocular infection or inflammation.
History of herpetic keratitis.
Any corneal distortion or irregular cornea.
History of binocular vision abnormality or strabismus.
Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
Current history of diabetes.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Central Ohio Eyecare
Columbus, Ohio, 43202
Baymeadows Vision Center
Jacksonville, Florida, 32256
Eye Elements Eyecare
Jacksonville, Florida, 32256
Vistakon Research Clinic
Jacksonville, Florida, 32256
Optometry Group LLC
Memphis, Tennessee, 38111
Nashville Vision Associates
Nashville, Tennessee, 37205
Golden Family Eyecare
Sarasota, Florida, 34232
Eye Associates of Winter Park
Winter Park, Florida, 32792

Other trials in United States

About this study

Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.

Conditions: Presbyopia
Being tested: etafilcon A (multi-focal), etafilcon A (sphere)
Medical subject headings: Presbyopia

What participants receive

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

etafilcon A (multi-focal)Device
Also called Investigational Multifocal Contact
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
etafilcon A (sphere)Device
Also called 1-DAY ACUVUE® MOIST®
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.

Study groups in NCT02310126
Study group	Role	What they receive
etafilcon A(sphere)/etafilcon A(multi-focal)	Active comparator	Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second. Receives: Device: etafilcon A (multi-focal); Device: etafilcon A (sphere)
etafilcon A(multi-focal)/etafilcon A(sphere)	Active comparator	Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second. Receives: Device: etafilcon A (multi-focal); Device: etafilcon A (sphere)

What is being measured

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

Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Measured: 15 minutes post Contact Lens Insertion

Timeline

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

1 Nov 20141 Dec 2014

First posted5 Dec 2014 (estimated)
Study start1 Nov 2014
Primary completion1 Dec 2014
Study completion1 Dec 2014

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 PresbyopiaStudies 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: Single blind
Who is masked: Participant
Enrolment: 195 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02310126
Sponsor's protocol ID: CR-5570
Status last verified: Jun 2017
First submitted: 3 Dec 2014
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

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

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

Questions to ask the study team

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

See locations

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia

All Presbyopia 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: Handling Comparison Between Two Contact Lens Types
ClinicalTrials.gov ID: NCT02310126
Acronym / sponsor ID: CR-5570
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 195 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Nov 2014 (actual)
Primary completion: 1 Dec 2014 (actual)
Study completion: 1 Dec 2014 (actual)
First posted: 5 Dec 2014 (estimated)
Results: Posted 31 Mar 2016

Clinical summary

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

Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.

Study design

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

Arm	Type	Receives
etafilcon A(sphere)/etafilcon A(multi-focal)	Active comparator	Device: etafilcon A (multi-focal), Device: etafilcon A (sphere)Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.
etafilcon A(multi-focal)/etafilcon A(sphere)	Active comparator	Device: etafilcon A (multi-focal), Device: etafilcon A (sphere)Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 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 between 40 and 70 years of age.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.
The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.

Key exclusion criteria (14 listed)

Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
Any ocular abnormality that may interfere with contact lens wear.
Use of any ocular medication, with the exception of rewetting drops.

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 (multi-focal)Also: Investigational Multifocal ContactEach subject will wear the soft contact lenses for 15 minutes then remove the lenses.	Device	etafilcon A(multi-focal)/etafilcon A(sphere), etafilcon A(sphere)/etafilcon A(multi-focal)
etafilcon A (sphere)Also: 1-DAY ACUVUE® MOIST®Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.	Device	etafilcon A(multi-focal)/etafilcon A(sphere), etafilcon A(sphere)/etafilcon A(multi-focal)

Primary outcome

Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
Time frame: 15 minutes post Contact Lens Insertion
CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

Results and safety

Results posted to the registry on 31 Mar 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
Etafilcon A(Multi-focal)/Etafilcon A(Sphere)	94	94
Etafilcon A(Sphere)/Etafilcon A(Multi-focal)	97	95

Primary outcome: Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.

Time frame: 15 minutes post Contact Lens Insertion. Mean (Standard Deviation). Unit: units on a scale

Measure	Etafilcon A(Multi-focal) n = 184	Etafilcon A (Sphere) n = 184
Hyperopes, N=69, N=69	53.44 (25.482)	55.81 (26.432)
Myopes, N=115, N=115	61.70 (24.594)	60.23 (23.369)

Population analysed: The analysis population consist of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens and strata.

Adverse events

Time frame: Throughout the duration of the study (approximately 1 month). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A (Multi-focal)	0 of 191 (0%)	0 of 191 (0%)	Not reported
Etafilcon A (Sphere)	0 of 191 (0%)	0 of 191 (0%)	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.

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia

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.

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

Questions about this trial

What is this clinical trial studying?

A study testing etafilcon A (multi-focal) and etafilcon A (sphere) in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 8 sites 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 10 inclusion and 14 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 8 sites 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 31 Mar 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?

Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. (time frame: 15 minutes post Contact Lens Insertion). 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 NCT02310126.

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.