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

June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
452

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: narafilcon B daily disposable 4 weeks
narafilcon B soft contact lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
Device: narafilcon B contact lens
Silicone Hydrogel Daily Disposable Contact Lenses
Active Comparator: nelfilcon A daily disponsable 1 week
nelfilcon A soft contact lenses worn daily on a daily disposable/replacement schedule, for 1 week
Device: nelfilcon A contact lens
Conventional Hydrogel Daily Disposable Contact Lenses
Active Comparator: lotrafilcon B daily wear, monthly replacement, 4-weeks
lotrafilcon B soft contact lenses worn daily on a 1-month replacement schedule, for 4 weeks
Device: lotrafilcon B contact lens
Silicone Hydrogel Monthly Replacement Contact Lenses

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After 1 week
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
After 1 Week
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.
After 4 Weeks
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.
After 4 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A
Time Frame: After 1 Week
Standard scale of 0 to 3 where 0=None, 3=Severe staining
After 1 Week
Subjective Rating of Overall Ease of Lens Handling 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.
After 1 Week
Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A
Time Frame: After 1 Week
Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort
After 1 Week
Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A
Time Frame: After 1 Week
Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.
After 1 Week
Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B
Time Frame: After 4 Weeks
Scale of 0 to 3, where 0=none and 3=severe staining.
After 4 Weeks
Subjective Rating of Overall Ease of Lens Handling 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.
After 4 Weeks
Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B
Time Frame: After 4 Weeks
Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort
After 4 Weeks
Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B
Time Frame: After 4 Weeks
Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.
After 4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Vision Care, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Visioncare Research Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-0917

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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