PresbyopiaNCT02223754

Evaluation of an Investigational Multifocal Lens

A study testing lotrafilcon B and etafilcon A in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 20 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

The purpose of this study is to test the performance of an investigational multifocal test soft contact lens. 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?: lotrafilcon B and etafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 371 participants
Where: 20 sitesUnited States
Study dates: Aug 2014to Nov 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 subjects were required to have read, understand, and signed 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.
Between 40 and 70 years of age.
Subjects must own a wearable pair of spectacles, if required for their distance vision.
Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration)
Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"*

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The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.
Refractive cylinder ≤ -0.75 D in each eye.
ADD power in the range +0.75 D to +2.50 D in each eye.
Best corrected visual acuity of 20/20-3 or better in each eye.

Who cannot join

Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
Any ocular or systemic allergies that may have contraindicated contact lens wear.
Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
Any ocular abnormality that may have interfered with contact lens wear.
Use of any ocular medication, with the exception of rewetting drops.
Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Denver, North Carolina, 28037
Study site
East Lansing, Michigan, 48823
Study site
Jacksonville, Florida, 32205
Study site
Jacksonville, Florida, 32250
Study site
Memphis, Tennessee, 38119
Study site
Mission Viejo, California, 92691
Study site
Montgomery, Alabama, 36109
Study site
Orange Park, Florida, 32065
Study site
Pittsburg, Kansas, 66762
Study site
Powell, Ohio, 43065
Study site
Roswell, Georgia, 30076
Study site
Saint Augustine, Florida, 32092
Study site
Salem, Virginia, 24153
Study site
Springfield, Ohio, 45503
Study site
Tallahassee, Florida, 32308
Study site
Tampa, Florida, 33625
Study site
Tyler, Texas, 75701
Study site
Vestal, New York, 13850
Study site
Warwick, Rhode Island, 02888
Study site
Winter Park, Florida, 32792

Other trials in United States

About this study

The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.

Conditions: Presbyopia
Being tested: lotrafilcon B, etafilcon A
Medical subject headings: Presbyopia

What participants receive

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

lotrafilcon BDevice
Also called AirOptix Aqua Multifocal
Soft contact lens to be worn as daily wear, monthly replacement modality.
etafilcon ADevice
Soft contact lens to be worn as daily wear, daily disposable modality.

Study groups in NCT02223754
Study group	Role	What they receive
lotrafilcon B / etafilcon A	Active comparator	Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens. Receives: Device: lotrafilcon B; Device: etafilcon A
etafilcon A / lotrafilcon B	Experimental	Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens. Receives: Device: lotrafilcon B; Device: etafilcon A

What is being measured

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

Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
CLUE Overall Quality of Vision 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: 8 -12 days post wear
Distance Binocular Visual Acuity (LogMAR)
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
Measured: 8- 12 Days post wear
Intermediate Binocular Visual Acuity (LogMAR)
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Measured: 8-12 days post wear
Near Binocular Visual Acuity (LogMAR)
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Measured: 8-12 days post wear
Corneal Staining
Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Measured: 8 - 12 Days post wear
Bulbar Conjunctival Injection
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Measured: 8- 12 Days post wear
Limbal Conjunctival Injection
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Measured: 8- 12 Days post wear
Contact Lens Fitting
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
Measured: 8- 12 Days post wear

Timeline

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

Aug 2014Nov 2014

First posted22 Aug 2014 (estimated)
Study startAug 2014
Primary completionNov 2014
Study completionNov 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 371 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02223754
Sponsor's protocol ID: CR-5593
Status last verified: Jul 2016
First submitted: 20 Aug 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

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Evaluation of Functional Superiority of the Morrow eProgressive
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Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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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: Evaluation of an Investigational Multifocal Lens
ClinicalTrials.gov ID: NCT02223754
Acronym / sponsor ID: CR-5593
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 371 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 22 Aug 2014 (estimated)
Results: Posted 31 Aug 2016

Clinical summary

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

The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
lotrafilcon B / etafilcon A	Active comparator	Device: lotrafilcon B, Device: etafilcon ASubject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.
etafilcon A / lotrafilcon B	Experimental	Device: lotrafilcon B, Device: etafilcon ASubject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.

Who may qualify

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

Key inclusion criteria (10 listed)

The subjects were required to have read, understand, and signed 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.
Between 40 and 70 years of age.
Subjects must own a wearable pair of spectacles, if required for their distance vision.
Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration)

Key exclusion criteria (14 listed)

Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).
Any ocular or systemic allergies that may have contraindicated contact lens wear.
Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.
Any ocular abnormality that may have interfered 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
lotrafilcon BAlso: AirOptix Aqua MultifocalSoft contact lens to be worn as daily wear, monthly replacement modality.	Device	etafilcon A / lotrafilcon B, lotrafilcon B / etafilcon A
etafilcon ASoft contact lens to be worn as daily wear, daily disposable modality.	Device	etafilcon A / lotrafilcon B, lotrafilcon B / etafilcon A

Primary outcome

Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
Time frame: 8 -12 days post wear
CLUE Overall Quality of Vision 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).
Distance Binocular Visual Acuity (LogMAR)
Time frame: 8- 12 Days post wear
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
Intermediate Binocular Visual Acuity (LogMAR)
Time frame: 8-12 days post wear
Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Near Binocular Visual Acuity (LogMAR)
Time frame: 8-12 days post wear
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Corneal Staining
Time frame: 8 - 12 Days post wear
Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Bulbar Conjunctival Injection
Time frame: 8- 12 Days post wear
The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Limbal Conjunctival Injection
Time frame: 8- 12 Days post wear
The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Contact Lens Fitting
Time frame: 8- 12 Days post wear
Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.

Results and safety

Results posted to the registry on 31 Aug 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 / Lotrafilcon B	163	159
Lotrafilcon B/ Etafilcon A	159	144

Primary outcome: Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire

Time frame: 8 -12 days post wear. Mean (Standard Deviation). Unit: units on a scale

Measure	Etafilcon A n = 275	Lotrafilcon B n = 275
Hyperopes, N=94, N=94	51.15 (21.647)	54.28 (20.749)
Myopes, N=181, N=181	53.55 (18.644)	51.84 (19.319)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Primary outcome: Distance Binocular Visual Acuity (LogMAR)

Time frame: 8- 12 Days post wear. Mean (Standard Deviation). Unit: LogMAR

Measure	Etafilcon A n = 275	Lotrafilcon B n = 275
Hyperopes, N=94, N=94	-0.069 (0.0908)	-0.066 (0.0982)
Myopes, N=180, N=181	-0.100 (0.0991)	-0.093 (0.0981)

Population analysed: The analysis population consists of subjects that have completed all study visits without a major protocol deviation.

Primary outcome: Intermediate Binocular Visual Acuity (LogMAR)

Time frame: 8-12 days post wear. Mean (Standard Deviation). Unit: LogMAR

Measure	Etafilcon A n = 275	Lotrafilcon B n = 275
Hyperopes, N=94, N=94	-0.061 (0.0829)	-0.050 (0.0897)
Myopes, N=180, N=181	-0.081 (0.0803)	-0.063 (0.0894)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Primary outcome: Near Binocular Visual Acuity (LogMAR)

Time frame: 8-12 days post wear. Mean (Standard Deviation). Unit: LogMAR

Measure	Etafilcon A n = 275	Lotrafilcon B n = 275
Hyperopes, N=94, N=94	0.050 (0.0970)	0.074 (0.1035)
Myopes, N=180, N=181	0.034 (0.1039)	0.049 (0.1176)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Adverse events

Time frame: Approximately 8-12 days per intervention.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A	0 of 307 (0%)	0 of 307 (0%)	Not reported
Lotrafilcon B	0 of 318 (0%)	0 of 318 (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
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing lotrafilcon B and etafilcon A in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 20 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 20 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 Aug 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 Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire (time frame: 8 -12 days post wear). The study lists 8 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 NCT02223754.

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; AzTrials last refreshed its copy on 7 Nov 2026.