PresbyopiaNCT01763047

Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population

A study testing etafilcon A and lotrafilcon B in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 19 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 objective of this study is to evaluate the performance of a novel multifocal lens system. 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 and lotrafilcon B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 298 participants
Where: 19 sitesUnited States
Study dates: Nov 2012to Feb 2013
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

Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
Subjects must be between 40 and 70 years of age.
Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.
Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.

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Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.
Subjects' should own a wearable pair of spectacles.
Subjects' must 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 or more duration).
Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).

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 previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
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.

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Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
History of binocular vision abnormality or strabismus.
Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
History of diabetes.
Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Study site
Amarillo, Texas
Study site
Athens, Ohio
Study site
Closter, New Jersey
Study site
Denver, North Carolina
RPS
Jacksonville, Florida
Study site
Jacksonville, Florida
Study site
Kingston, Pennsylvania
Study site
Lutherville, Maryland
Study site
Memphis, Tennessee
Study site
Mission Viejo, California
Study site
New York, New York
Study site
Roswell, Georgia
Study site
Saint Augustine, Florida
Study site
Salem, Virginia
Study site
Salt Lake City, Utah
Study site
Tallahassee, Florida
Study site
Tyler, Texas
Study site
Warwick, Rhode Island
Study site
Winter Park, Florida

Other trials in United States

About this study

The objective of this study is to evaluate the performance of a novel multifocal lens system.

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

What participants receive

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

etafilcon ADevice
To be worn in a daily wear modality for a minimum of 6 hours per day.
lotrafilcon BDevice
Also called AirOptix Aqua Multifocal
Lenses will be worn in a reuseable modality; cleaned and disinfected each night.

Study groups in NCT01763047
Study group	Role	What they receive
etafilcon A/lotrafilcon B	Active comparator	Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the etafilcon A lens and then wore the lotrafilcon B lens. Receives: Device: etafilcon A; Device: lotrafilcon B
lotrafilcon B/etafilcon A	Active comparator	Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the lotrafilcon B lens and then wore the etafilcon A lens. Receives: Device: etafilcon A; Device: lotrafilcon B

What is being measured

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

Binocular Distance Visual Acuity (LogMAR)
Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)
Measured: 8-12 days post wear
Binocular Near Visual Acuity (logMAR)
Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).
Measured: 8-12 days post wear
Percentage of Eyes With Corneal Staining Grade 3 or Higher
Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) 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 and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.
Measured: 8-12 days post wear
Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher
The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) 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 Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
Measured: 8-12 days post wear
Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher
Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) 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 for the maximum grade of all 4 regions.
Measured: 8-12 days post wear
CLUE 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

Timeline

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

Nov 2012Feb 2013

First posted8 Jan 2013 (estimated)
Study startNov 2012
Primary completionFeb 2013
Study completionFeb 2013

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: 298 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01763047
Sponsor's protocol ID: CR-5357
Status last verified: May 2016
First submitted: 17 Dec 2012
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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VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
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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 the Performance of Investigational Contact Lenses in a Presbyopic Population
ClinicalTrials.gov ID: NCT01763047
Acronym / sponsor ID: CR-5357
Conditions: Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 298 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 8 Jan 2013 (estimated)
Results: Posted 10 Jun 2016

Clinical summary

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

The objective of this study is to evaluate the performance of a novel multifocal lens system.

Study design

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

Arm	Type	Receives
etafilcon A/lotrafilcon B	Active comparator	Device: etafilcon A, Device: lotrafilcon BSubjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the etafilcon A lens and then wore the lotrafilcon B lens.
lotrafilcon B/etafilcon A	Active comparator	Device: etafilcon A, Device: lotrafilcon BSubjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the lotrafilcon B lens and then wore the etafilcon A lens.

Who may qualify

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

Key inclusion criteria (10 listed)

Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
Subjects must be between 40 and 70 years of age.
Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.

Key exclusion criteria (11 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 previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
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.

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 ATo be worn in a daily wear modality for a minimum of 6 hours per day.	Device	etafilcon A/lotrafilcon B, lotrafilcon B/etafilcon A
lotrafilcon BAlso: AirOptix Aqua MultifocalLenses will be worn in a reuseable modality; cleaned and disinfected each night.	Device	etafilcon A/lotrafilcon B, lotrafilcon B/etafilcon A

Primary outcome

Binocular Distance 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, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)
Binocular Near 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, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).
Percentage of Eyes With Corneal Staining Grade 3 or Higher
Time frame: 8-12 days post wear
Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) 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 and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.
Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher
Time frame: 8-12 days post wear
The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) 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 Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher
Time frame: 8-12 days post wear
Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) 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 for the maximum grade of all 4 regions.
CLUE 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).

Results and safety

Results posted to the registry on 10 Jun 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	139	130
Lotrafilcon B/ Etafilcon A	137	126

Primary outcome: Binocular Distance Visual Acuity (LogMAR)

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

Measure	Etafilcon A n = 207	Lotrafilcon B n = 207
Hyperopes, N=91, 91	-0.068 (0.0885)	-0.058 (0.0867)
Myopes, N=116, N=116	-0.109 (0.0826)	-0.107 (0.0835)

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

Primary outcome: Binocular Near Visual Acuity (logMAR)

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

Measure	Etafilcon A n = 207	Lotrafilcon B n = 207
Hyperopes, N=91, N=91	0.063 (0.1070)	0.082 (0.1316)
Myopes, N=116, N=116	0.048 (0.1106)	0.043 (0.0975)

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

Primary outcome: Percentage of Eyes With Corneal Staining Grade 3 or Higher

Time frame: 8-12 days post wear. Number. Unit: Percentage of Subject Eyes

Measure	Etafilcon A n = 207	Lotrafilcon B n = 207
Hyperopes, N=182, N=182	0.0	0.0
Myopes, N=232, N=232	0.0	0.0

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

Primary outcome: Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher

Time frame: 8-12 days post wear. Number. Unit: Percentage of Subject Eyes

Measure	Etafilcon A n = 207	Lotrafilcon B n = 207
Hyperopes, N=182, N=182	0.0	0.0
Myopes, N=232, N=232	0.0	0.0

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

Adverse events

Time frame: Throughout the duration of the study- approximately 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test (Etafilcon A)	0 of 276 (0%)	0 of 276 (0%)	Not reported
Control (Lotrafilcon B)	0 of 276 (0%)	0 of 276 (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.

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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.

19 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 and lotrafilcon B in people with Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 19 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 11 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 19 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 10 Jun 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?

Binocular Distance Visual Acuity (LogMAR) (time frame: 8-12 days post wear). 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 NCT01763047.

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.