MyopiaNCT01093625

Assessment of Daily Disposable Silicone Hydrogel Lens Wear

A study testing Narafilcon B Contact Lens and Spectacles in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers. Read more about this study

Who is it for?: Ages 15 to 39 years
Conditions the study is for: Myopia
What is being tested?: Narafilcon B Contact Lens and Spectacles
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 157 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Apr 2011
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 15 to 39 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
Willing to comply with the study visit schedule.
Ages 15 to 39.
Has access to a cellular telephone with text messaging capabilities.
Has a current pair of spectacles.
'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.

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Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
They agree not to participate in other clinical research during the duration of this study.

Who cannot join

Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
Systemic disease, which might interfere with contact lens wear.
Medication usage that may be associated with eye dryness.
Use of any topical medication such as eye drops or ointment.
Pregnant or lactating (by self-report).

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Aphakia.
Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
Have participated in any other clinical trial or research in the two weeks prior to starting this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Conditions: Myopia
Being tested: Narafilcon B Contact Lens, Spectacles
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
Also called Investigational Silicone Hydrogel
SpectaclesDevice
spectacle wearers

Study groups in NCT01093625
Study group	Role	What they receive
Narafilcon B Contact Lens	Experimental	Investigational Silicone Hydrogel Contact Lens Receives: Device: Narafilcon B Contact Lens
Spectacles	Active comparator	Not described Receives: Device: Spectacles

What is being measured

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

Papillary Conjunctivitis
Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Measured: 1 Year
Conjunctival Hyperemia
Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Measured: 1 Year
Limbal Hyperemia
Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Measured: 1 Year
Corneal Staining
Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.
Measured: 1 Year
Conjunctival Staining
Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Measured: 1 Year
Corneal Neovascularization
New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Measured: 1 Year
Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire
The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.
Measured: 1 Year

Secondary outcomes (1)

Comfortable Wearing Time
Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.
Measured: 1 Year

Timeline

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

Jan 2010Apr 2011

First posted26 Mar 2010 (estimated)
Study startJan 2010
Primary completionApr 2011
Study completionApr 2011

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: Investigator
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01093625
Sponsor's protocol ID: CR-0916
Status last verified: May 2015
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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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: Assessment of Daily Disposable Silicone Hydrogel Lens Wear
ClinicalTrials.gov ID: NCT01093625
Acronym / sponsor ID: CR-0916
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: Ohio State University
Study start: Jan 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 26 Mar 2010 (estimated)
Results: Posted 13 Feb 2014

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 evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Narafilcon B Contact Lens	Experimental	Device: Narafilcon B Contact LensInvestigational Silicone Hydrogel Contact Lens
Spectacles	Active comparator	Device: Spectacles

Who may qualify

Ages: 15 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
Willing to comply with the study visit schedule.
Ages 15 to 39.
Has access to a cellular telephone with text messaging capabilities.
Has a current pair of spectacles.

Key exclusion criteria (9 listed)

Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
Systemic disease, which might interfere with contact lens wear.
Medication usage that may be associated with eye dryness.
Use of any topical medication such as eye drops or ointment.

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 LensAlso: Investigational Silicone Hydrogel	Device	Narafilcon B Contact Lens
Spectaclesspectacle wearers	Device	Spectacles

Primary outcome

Papillary Conjunctivitis
Time frame: 1 Year
Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Conjunctival Hyperemia
Time frame: 1 Year
Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Limbal Hyperemia
Time frame: 1 Year
Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Corneal Staining
Time frame: 1 Year
Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.
Conjunctival Staining
Time frame: 1 Year
Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Corneal Neovascularization
Time frame: 1 Year
New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire
Time frame: 1 Year
The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.

1 secondary outcome

Comfortable Wearing Time
Time frame: 1 Year

Results and safety

Results posted to the registry on 13 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Silicone Hydrogel Contact Lens	49	47
Spectacles	49	49

Primary outcome: Papillary Conjunctivitis

Time frame: 1 Year. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Investigational Silicone Hydrogel Contact Lens n = 29	Spectacles n = 37
Value	0.98 (0.83 to 1.14)	0.47 (0.32 to 0.61)

Population analysed: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

Primary outcome: Conjunctival Hyperemia

Time frame: 1 Year. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Investigational Silicone Hydrogel Contact Lens n = 29	Spectacles n = 37
Value	0.26 (0.13 to 0.39)	0.28 (0.17 to 0.39)

Population analysed: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

Primary outcome: Limbal Hyperemia

Time frame: 1 Year. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Investigational Silicone Hydrogel Contact Lens n = 29	Spectacles n = 37
Value	0.56 (0.45 to 0.67)	0.30 (0.19 to 0.40)

Population analysed: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

Primary outcome: Corneal Staining

Time frame: 1 Year. Least squares mean (95% Confidence Interval). Unit: Efron Scale (0.1 Unit increments)

Measure	Investigational Silicone Hydrogel Contact Lens n = 29	Spectacles n = 37
Value	0.26 (0.21 to 0.30)	0.12 (0.07 to 0.16)

Population analysed: Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Silicone Hydrogel Contact Lens	0 of 49 (0%)	0 of 49 (0%)	Not reported
Spectacles	0 of 49 (0%)	0 of 49 (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.

1 site 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 and Spectacles in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 9 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 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 13 Feb 2014). 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?

Papillary Conjunctivitis (time frame: 1 Year). The study lists 7 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 NCT01093625.

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.