MyopiaNCT01151371

Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens

A study testing narafilcon B contact lens, nelfilcon A contact lens and lotrafilcon B contact lens in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 28 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 the study is to compare the clinical performance of silicone hydrogel daily disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone hydrogel monthly replacement contact lenses. Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Myopia
What is being tested?: narafilcon B contact lens, nelfilcon A contact lens and lotrafilcon B contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 452 participants
Where: 28 sitesUnited States
Study dates: 1 Feb 2010to 1 Apr 2010
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 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Be no less than 18 and no more than 39 years of age.
Sign Written Informed Consent and investigator to record this on Case Report Form (See separate document).
Be willing and able to adhere to the instructions set out in the protocol.
Own a cell phone and be willing to receive text messages during the day.
Be an existing successful daily wear soft contact lens. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
No extended wear in the last 3 months.

Show all 17Show fewer

Subjective refraction must result in a vertexed spherical contact lens prescription between -1.00 and -6.00D.
Have refractive astigmatism less than or equal to 1.00D in both eyes.
Achieve visual acuity of 6/9 (20/30) or better in each eye.
Require a visual correction in both eyes (no monofit or monovision allowed).
Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia.
No evidence of lid abnormality or infection (including blepharitis/meibomitis).
No conjunctival abnormality or infection.
No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
No other active ocular disease.

Who cannot join

Requires concurrent ocular medication.
Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
Clinically significant corneal staining (Grade 3 in more than one corneal region per eye).
Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
Has had refractive surgery.
Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.

Show all 17Show fewer

Abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.
Keratoconus or other corneal irregularity.
PMMA(polymethyl methacrylate), hybrid or RGP(rigid gas permeable) lens wear in the previous 8 weeks.
Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV (Human immunodeficiency virus)).
History of chronic eye disease (e.g. glaucoma or ARMD (age related macular degeneration)).
Pregnancy, lactating or planning a pregnancy at the time of enrolment.
Participation in any concurrent clinical trial or in last 30 days.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Study site
Bartlett, Tennessee
Study site
Blue Springs, Missouri
Study site
Boston, Massachusetts
Study site
Brea, California
Study site
Brentwood, Tennessee
Study site
Bridgeport, Connecticut
Study site
Burlington, Vermont
Study site
Canoga Park, California
Study site
Chagrin Falls, Ohio
Study site
Corona, California
Study site
Independence, Missouri
Study site
Jacksonville, Florida, 32205
Study site
Jacksonville, Florida, 32256
Study site
Kittanning, Pennsylvania
Study site
Lake Ozark, Missouri
Study site
Mishawaka, Indiana
Study site
New York, New York
Study site
North Olmsted, Ohio
Study site
Raleigh, North Carolina
Study site
Roswell, Georgia
Study site
State College, Pennsylvania
Study site
Tampa, Florida
Study site
Tyler, Texas, 75701
Study site
Tyler, Texas, 75703
Study site
Virginia Beach, Virginia
Study site
Warren, Ohio
Study site
Warwick, Rhode Island
Study site
Winter Park, Florida

Other trials in United States

About this study

Conditions: Myopia
Being tested: narafilcon B contact lens, nelfilcon A contact lens, lotrafilcon B contact lens
Medical subject headings: Myopia

What participants receive

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

narafilcon B contact lensDevice
Silicone Hydrogel Daily Disposable Contact Lenses
nelfilcon A contact lensDevice
Conventional Hydrogel Daily Disposable Contact Lenses
lotrafilcon B contact lensDevice
Silicone Hydrogel Monthly Replacement Contact Lenses

Study groups in NCT01151371
Study group	Role	What they receive
narafilcon B daily disposable 4 weeks	Experimental	narafilcon B soft contact lenses worn daily on a daily disposable/replacement schedule, for 4 weeks Receives: Device: narafilcon B contact lens
nelfilcon A daily disponsable 1 week	Active comparator	nelfilcon A soft contact lenses worn daily on a daily disposable/replacement schedule, for 1 week Receives: Device: nelfilcon A contact lens
lotrafilcon B daily wear, monthly replacement, 4-weeks	Active comparator	lotrafilcon B soft contact lenses worn daily on a 1-month replacement schedule, for 4 weeks Receives: Device: lotrafilcon B contact lens

What is being measured

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

Overall Comfort Narafilcon B v. Nelfilcon A
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Measured: After 1 week
Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A
Redness scale of 0 to 4, where 0=None, 4=Severe redness
Measured: After 1 Week
Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Measured: After 4 Weeks
Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B
Redness scale of 0 to 4, where 0=None, and 4=Severe.
Measured: After 4 Weeks

Secondary outcomes (8)

Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A
Standard scale of 0 to 3 where 0=None, 3=Severe staining
Measured: After 1 Week
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Measured: After 1 Week
Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A
Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort
Measured: After 1 Week
Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A
Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.
Measured: After 1 Week
Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B
Scale of 0 to 3, where 0=none and 3=severe staining.
Measured: After 4 Weeks
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Measured: After 4 Weeks
Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B
Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort
Measured: After 4 Weeks
Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B
Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.
Measured: After 4 Weeks

Timeline

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

1 Feb 20101 Apr 2010

First posted28 Jun 2010 (estimated)
Study start1 Feb 2010
Primary completion1 Apr 2010
Study completion1 Apr 2010

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 MyopiaStudies 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 452 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01151371
Sponsor's protocol ID: CR-0917
Status last verified: Aug 2017
First submitted: 24 Mar 2010
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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Myopia 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 Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens
ClinicalTrials.gov ID: NCT01151371
Acronym / sponsor ID: CR-0917
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 452 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: Visioncare Research Ltd.
Study start: 1 Feb 2010 (actual)
Primary completion: 1 Apr 2010 (actual)
Study completion: 1 Apr 2010 (actual)
First posted: 28 Jun 2010 (estimated)
Results: Posted 19 Dec 2011

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
narafilcon B daily disposable 4 weeks	Experimental	Device: narafilcon B contact lensnarafilcon B soft contact lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
nelfilcon A daily disponsable 1 week	Active comparator	Device: nelfilcon A contact lensnelfilcon A soft contact lenses worn daily on a daily disposable/replacement schedule, for 1 week
lotrafilcon B daily wear, monthly replacement, 4-weeks	Active comparator	Device: lotrafilcon B contact lenslotrafilcon B soft contact lenses worn daily on a 1-month replacement schedule, for 4 weeks

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (17 listed)

Be no less than 18 and no more than 39 years of age.
Sign Written Informed Consent and investigator to record this on Case Report Form (See separate document).
Be willing and able to adhere to the instructions set out in the protocol.
Own a cell phone and be willing to receive text messages during the day.
Be an existing successful daily wear soft contact lens. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.

Key exclusion criteria (17 listed)

Requires concurrent ocular medication.
Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
Clinically significant corneal staining (Grade 3 in more than one corneal region per eye).
Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
Has had refractive surgery.

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
narafilcon B contact lensSilicone Hydrogel Daily Disposable Contact Lenses	Device	narafilcon B daily disposable 4 weeks
nelfilcon A contact lensConventional Hydrogel Daily Disposable Contact Lenses	Device	nelfilcon A daily disponsable 1 week
lotrafilcon B contact lensSilicone Hydrogel Monthly Replacement Contact Lenses	Device	lotrafilcon B daily wear, monthly replacement, 4-weeks

Primary outcome

Overall Comfort Narafilcon B v. Nelfilcon A
Time frame: After 1 week
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A
Time frame: After 1 Week
Redness scale of 0 to 4, where 0=None, 4=Severe redness
Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B
Time frame: After 4 Weeks
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B
Time frame: After 4 Weeks
Redness scale of 0 to 4, where 0=None, and 4=Severe.

8 secondary outcomes

Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A
Time frame: After 1 Week
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A
Time frame: After 1 Week
Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A
Time frame: After 1 Week
Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A
Time frame: After 1 Week
Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B
Time frame: After 4 Weeks
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B
Time frame: After 4 Weeks
Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B
Time frame: After 4 Weeks
Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B
Time frame: After 4 Weeks

Results and safety

Results posted to the registry on 19 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Narafilcon B 4 Weeks	149	144
Nelfilcon A 1 Week	150	149
Lotrafilcon B 4 Weeks	153	146

Primary outcome: Overall Comfort Narafilcon B v. Nelfilcon A

Time frame: After 1 week. Mean (Standard Deviation). Unit: units on a scale

Measure	Narafilcon B n = 147	Nelfilcon A n = 148
Value	68.32 (22.82)	53.75 (23.71)

Primary outcome: Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A

Time frame: After 1 Week. Mean (Standard Deviation). Unit: Units on a scale

Measure	Narafilcon B n = 147	Nelfilcon A n = 148
Value	0.53 (0.50)	0.61 (0.51)

Primary outcome: Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B

Time frame: After 4 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Narafilcon B n = 142	Lotrafilcon B n = 143
Value	66.43 (23.37)	53.91 (23.72)

Primary outcome: Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B

Time frame: After 4 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Narafilcon B n = 142	Lotrafilcon B n = 143
Value	0.44 (0.47)	0.68 (0.61)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Narafilcon B 4 Weeks	0 of 149 (0%)	0 of 149 (0%)	Not reported
Nelfilcon A 1 Week	0 of 150 (0%)	0 of 150 (0%)	Not reported
Lotrafilcon B 4 Weeks	0 of 153 (0%)	0 of 153 (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.

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

Questions about this trial

What is this clinical trial studying?

A study testing narafilcon B contact lens, nelfilcon A contact lens and lotrafilcon B contact lens in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 28 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 17 inclusion and 17 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 28 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 19 Dec 2011). 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 Narafilcon B v. Nelfilcon A (time frame: After 1 week). The study lists 4 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 NCT01151371.

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.